Devices, treatments and methods to restore tissue elastic recoil

ABSTRACT

Pulmonary treatment devices, systems and methods of use are provided which take into account the vast tissue damage of advanced COPD sufferers and provide treatments designed specifically to treat the particularly compromised lung tissues that are present in these patients. These treatments reduce trapped air volume, tension lung tissue and enhance lung elastic recoil. In particular, a variety of embodiments of invertible pulmonary treatment devices are provided. The devices are comprised of a shape memory material wherein the devices are able to be expanded under tension, and then are able to recoil back toward an original relaxed or resting shape. In these embodiments, a portion of the device is invertible. Thus, each device is able to store energy at least in the inversion, wherein the energy is utilized to continually tension the lung as the device relaxes toward its original shape.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT Application No. PCT/US20/63755(Attorney Docket No. 52086-707601), filed Dec. 8, 2020, which claims thebenefit of U.S. Provisional No. 62/945,510 (Attorney Docket No.52086-707.101), filed Dec. 9, 2019, the entire content of which isincorporated herein by reference.

BACKGROUND OF THE INVENTION

Chronic obstructive pulmonary disease (COPD) is a common progressive,debilitating lung disease that is often fatal. COPD patients arediagnosed with either emphysema, chronic bronchitis or more commonly, acombination of both. The symptoms of COPD include a persistent cough,particularly one that produces excessive of mucus, shortness of breath(especially during exercise), a wheezing sound while breathing, abarrel-chest deformity, and tightness in the chest muscles due toexpansion of the chest with the barrel-chest deformation. Late stages ofCOPD manifest in symptoms that relate more closely to slow persistentsuffocation as the disease eventually nearly totally obstructs anyoutflow of gas from the lungs. Such symptoms may start as a minorimpediment to daily life, but they often lead to difficulty in talkingor basic breathing. COPD reduces oxygen and carbon dioxide gas exchangewhich leads to circulatory problems, such as low oxygen levels in theblood, brain and heart muscles. This negatively affects mental alertnessand contributes to a very rapid heartbeat, due to increased strain onthe heart.

According to the National Institutes of Health, COPD is the thirdleading cause of death in the United States. The American LungAssociation reports that more than 11 million people in the UnitedStates have been diagnosed with COPD. However, about 24 million morepeople may have the disease and not know it. Globally, COPD affectsapproximately 65 million people.

COPD can occur in people suffering from an inherited genetic conditioncalled Alpha-1 Antitrypsin Deficiency (A1AT Deficiency) and frombreathing air in environmental conditions such as air pollution,contaminated air, in work environments that are not ideal etc. However,COPD most commonly occurs in people who are over age 40 and who have ahistory of smoking. Cigarette smoke is composed of over 4000 differentchemicals, many of which are toxic. Both smoke that the smoker inhales(through the filter) and the smoke from the burning end are toxic. Thereare three main components that are hazardous to health: tar, nicotineand carbon monoxide. Tar settles in the lungs and stimulates a series ofchanges that lead to obstructive lung disease and lung cancer. Nicotineis an addictive element in cigarettes and also stimulates the nervoussystem to reduce arteriole diameter and release adrenaline, increasingheart rate and blood pressure. Nicotine also causes increased stickinessof blood platelets, which increases the risk of blood clotting. Carbonmonoxide combines irreversibly with hemoglobin so that oxygen cannotbind effectively. This causes a strain on the heart muscle because itmust pump more to provide the same amount of oxygen.

Tobacco smoke and secondhand smoke travel down through the windpipe andinto the bronchial tubes. The toxic smoke then moves into thebronchioles, which contain the small clusters of air sacs known asalveoli. Within the alveoli are the capillaries. In a healthy person,oxygen moves through the alveoli and into the capillaries andbloodstream during inhalation, allowing oxygen rich blood to bedistributed to the rest of the body via the arterial system.Simultaneously, carbon dioxide is transported from blood along venouspathways to the capillaries and into the alveoli so it can be removedfrom the body during exhalation. This process is known as gas exchange.The elasticity of healthy air sacs enables this exchange to occur duringlung volume change with breathing cycles. However, the inhalation ofsmoke ultimately destroys this elasticity and lung tissue itself.

The effect of tobacco smoke on lung elastin is extremely complicated,affecting many facets of connective tissue metabolism. Inhalation ofcigarette smoke causes an accumulation in the respiratory bronchi ofalveolar macrophages, which appear to be filled with pigments and aremetabolically and morphologically activated. The activated macrophagehas the ability to secrete chemo attractants and secretagogues forneutrophils, as well as secrete a metalloprotease capable of digestingelastin and al antiprotease. The end result is a clustering of largenumbers of neutrophils and macrophages, poised to release considerableamounts of elastolytic enzymes at the site where the earliest signs ofcentrilobular emphysema are detected. This is seen, in X-ray images ofthe lung as small pockets of dissolved tissue known as blebs. Inaddition to this, the alveolar macrophages, as well as cigarette smoke,are rich sources of oxidizing agents. One potential action of theseoxidants would be to oxidize the methionine residue found at the activesite of al proteinase inhibitor. This has been shown by selectivechemical oxidation to yield a relatively ineffective inhibitor thatassociates with elastase some 2000 times more slowly than the nativeprotein. This results in oxidant damage to lung cells and cellularcomponents such as lipids, cofactors, and nucleic acids. Endogenousantioxidant systems within the lung, such as ceruloplasmin, vitamin C,or methionine sulphoxide-peptide reductase, are adversely affected bycigarette smoke, lowering the lung's defense against oxidants. Theelastin maturation process is impaired by cigarette smoke.

Such damage affects the walls between the alveolar sacs. As the air sacsweaken, their walls break open or “melt”, creating one large air sacinstead of many smaller ones. The total surface area of the air sacs isreduced, and this reduces that amount of gas that can be exchangedacross the walls of the air sacs. These gasses are transported acrossthe thin air sac membrane surfaces using a diffusion process. Byreducing the majority of air sacs, the total surface area of the sacs islimited causing gas exchange to be reduced. This makes it more difficultfor the capillaries to absorb enough oxygen and for the body to expelcarbon dioxide, making it progressively harder to breathe. In addition,the air sacs lose their elasticity making it harder to recoil and expelair. The walls of the airways thicken and become swollen while makingmore mucus than normal which can clog the airways that lead to the airsacs. The thickening and mucus plugging are the chronic bronchitiscomponent of COPD. All of these factors contribute to the symptoms ofCOPD.

Another common COPD symptom is air trapping which causes breathingdisfunction as well as lobar and lung hyperinflation. The reduced volumereached by the lungs after exhalation is determined by the balance offorces between the inward elastic recoil pressure, or inward pullingtension of the lung tissue that lifts the diaphragm and the outwardrecoil pressure or outward pulling of the chest wall. The lung issuspended in an expanded state due to negative pressure or vacuumbetween the chest wall and the exterior lining of the lung. This vacuumkeeps the lung expanded and pinned to the chest wall. Because the lungsare held in a generally expanded state, interior lung tissue(parenchyma) is stressed in tension (creating lung elastic resistance tostretching, commonly referred to as lung elastic recoil). This tension,throughout the lung, pulls radially outward on the airways to hold theseairways open and the tension helps to allow air to be squeezed out ofthe lungs during the expiration breathing cycle. During expiration, thediaphragm muscle is relaxed, and the lung's internal elastic recoillifts the diaphragm and lung floor up which reduces the lung volume andsqueezes air out of the lung. During inspiration, the diaphragm musclecontracts to pull the diaphragm down which increase lung volume whichdraws air back into the lungs. Static hyperinflation occurs when thelungs exert less recoil pressure to counter the recoil pressure of thechest wall due to the destruction of elastin. This results in anequilibrium of recoil forces at a higher resting volume than normal. Inother words, there is less recoil so the diaphragm cannot be lifted asfar and the lungs ability to expel air is reduced. This creates achronic increase in lung volume, also known as increased total lungcapacity (TLC). Dynamic hyperinflation occurs when air is trapped withinthe lungs after each breath due to a disequilibrium between the volumesinhaled and exhaled. This most commonly occurs during exercise andinspiration is more efficient than expiration. With each breath,hyperinflation is increased. The ability to fully exhale depends on thedegree of airflow limitation and the time available for exhalation. Bothtypes of air trapping causes 1) lung gas congestion, preventing newoxygen from being inspired, 2) retainment of CO2 in the lung and bloodstream (hypoxemia) and 3) crushing of better functioning lobes makingthem incapable of inspiration or expiration. The last phenomenon occursbecause the trapping often occurs in places with the most lung tissuedestruction (regions with the greatest reduction of recoil). As more airis trapped in this area and the lobe hyperinflates, it expands intoregions where tissue is better preserved and still performing well butthe added pressure of the inflated tissue restricts air flow in and outof the healthier region.

Ultimately, enzymes destroy and eliminate airways and alveoli tissue.Large holes are formed in alveoli beds forming pulmonary blebs andbullae. Pulmonary blebs are small subpleural thin walled air pockets,not larger than 1-2 cm in diameter. Their walls are less than 1 mmthick. If they rupture, they allow air to escape into the pleural spacebetween the lung and chest wall, which is normally holding the lungsexpanded and pinned to the chest wall with vacuum, resulting in aspontaneous pneumothorax or collapse of the lung. Pulmonary bullae, likeblebs, are cystic air spaces or pockets that have an imperceptible wall(less than 1 mm). The difference between blebs and bullae is generallyconsidered to be their size, with the cross-over being around 2 cm indiameter. Blebs may, over time, coalesce to form bullae.

Smoking cessation continues to be an important therapeutic interventionfor COPD. Approaches to management by stage include the following:

Stage I (mild obstruction): Short-acting bronchodilator as needed;Stage II (moderate obstruction): Short-acting bronchodilator as needed;long-acting bronchodilator(s); cardiopulmonary rehabilitation;Stage III (severe obstruction): Short-acting bronchodilator as needed;long-acting bronchodilator(s); cardiopulmonary rehabilitation; inhaledglucocorticoids if repeated exacerbations;

Stage IV (very severe obstruction or moderate obstruction with evidenceof chronic respiratory failure): Short-acting bronchodilator as needed;long-acting bronchodilator(s); cardiopulmonary rehabilitation; inhaledglucocorticoids if repeated exacerbation; long-term oxygen therapy (ifcriteria met); interventions such as lung transplantation, lung volumereduction surgery (LVRS), or implantable therapeutic devices.

Lung volume reduction surgery (LVRS) is a surgical procedure to removediseased, emphysematous lung tissue. The surgery removes up to ⅓ of thelung to attempt to remove non-gas exchanging portions of lung. This isintended to remove sections of non-performing tissue that can no longerexchange gas to and from the blood stream. It is also intended to removeblood vessels that would otherwise shunt under oxygenated blood withhigh levels of CO2 (vessels traveling through portions of the lung wheregas cannot be exchanged) back to the heart and blood circulatory system.However, this surgery presents patients with high risk of surgeryrelated morbidity and mortality. Patients who already have distressedbreathing due to the disease are further stressed with severe orthopedictrauma due to a sternotomy, which presents difficulty in reviving thesepatients from general anesthesia. LVRS related mortality and morbidityis a common result as was published in the National Emphysema TreatmentTrial (NETT) report. NETT was a multicenter, randomized, controlledclinical trial, comparing the efficacy of lung volume reduction surgery(LVRS) plus medical management with rehabilitation to medical managementwith rehabilitation in 1,218 patients with severe emphysema.

LVRS is performed with a long simple excision to remove a large portionof lung volume. Thus, it is not discriminative in the tissue that isremoved. LVRS also removes portions of remaining intact lung that wouldotherwise exchange gas. This reduces lung capacity that patients need toexchange gas. LVRS is also not effective for homogenous disease, whichis the type that most COPD patients suffer from. In homogenous disease,the disease is spread evenly in all lobes without a discrete target lungvolume that can be sacrificed to enhance lung elastic recoil. Homogenouspatients need therapy because they suffer from an insufficient lungcapacity to exchange gas. Removing more lung tissue only reduces theircapacity. Therefore, the surgery actually degrades these patient'sability to breathe.

A variety of implantable therapeutic devices have been developed toassist in treating COPD sufferers. One such device is an endobronchialvalve. An endobronchial valve is minimally invasive alternative to lungvolume reduction surgery (LVRS). Endobronchial valves were designed toreplicate the effects of that procedure without requiring incisions byallowing the most diseased lobe of a lung to be pneumatically blockedoff so air can be evacuated to cause the treatment lobe to collapse. Anendobronchial valve is a small, one-way valve that is typicallyimplanted such that when a patient exhales, air is able to flow throughthe valve and out of the lobe, but when the patient inhales, the valvecloses and blocks air from entering that lobe. Thus, a set of implantedendobronchial valves can help a lobe to empty itself of air. This hasbeen shown to be beneficial in the treatment of a very small populationof patients suffering from heterogenous emphysema, however suchendobronchial valves suffer from some of the same limitations as LVRS.Endobronchial valves that succeed to collapse lobes in homogenouspatients reduce their already insufficient lung capacity. Homogeneousdisease is the type that most COPD patients suffer from. Thus, thevalves may actually degrade these patient's ability to breathe. Anotherlimitation with the valves is the fact that approximately 80% ofpatients present with additional flow paths that lead into the lobe inaddition to the major airway tree that is typically shown in anatomytexts. The valves are designed to block flow in airways but in themajority of patients, total blockage or perfect pneumatic isolation cannever be achieved and the lobe never collapses. Many times, thealternate flow paths are created by enzyme destruction due to thedisease itself. This is particularly true in heterogenous patients wheretissue damage is concentrated.

A similar type of therapy involves an endoscopic volume reduction usinglung sealant. The lung sealant foam is instilled into the peripheralairways and alveoli where it polymerizes and functions as tissue glue onthe lungs inner surfaces in order to seal the target region to causedurable irreversible absorption atelectasis or collapse of the lungtissue. Such treatment by a biological sealant produces an irreversiblechange in emphysematous tissue. The biological sealant is delivered tothe alveolar compartment as separate liquid components via a dual lumencatheter passed through the instrument channel of a flexiblebronchoscope. A common side effect is a systemic flu-like inflammatoryreaction after the foam sealant application accompanied by transientfever, cough, bronchospasm, chest pain, leukocytosis, malaise, andelevated C-reactive protein levels. This side effect is sometimesself-limited and resolves within 24-96 h spontaneously. Other times, theinflammation can cause long term morbidity and even mortality. Otherserious pulmonary side effects within 6 months after the procedureinclude repetitive COPD exacerbations, pneumonia, bronchitis, andhemoptysis. Over a period of several weeks, the treated lung region willstart to shrink, reducing lung volume by atelectasis. However, suchtreatment again ultimately suffers from some of the same limitations asLVRS. In particular, lung sealants destroy lung tissue and reduce lungcapacity so they are not effective for homogenous disease, which is thetype that most COPD patients suffer from. Thus, these techniquesactually degrade these patient's ability to breathe.

Endobronchial coils are another type of therapeutic device developed toassist in treating COPD sufferers and act as a minimally invasivealternative to lung volume reduction surgery (LVRS). Endobronchial coilsare nitinol devices implanted bronchoscopically under fluoroscopicguidance. The coils are straightened so they can be passed through abronchoscope and into airways for deployment and then they are pushedout of the catheter and allowed to recover to a programmed shape thatbends the airway they are deployed into. The device bends the airway tocompress adjacent tissue to cause a small lung volume reduction effect.As multiple coils revert to their original double-loop shape within theairways, targeted pockets of lung tissue are compressed between featuresof the coil to replicate the effects of the LVRS in a minimally invasivetreatment. Multiple coils implanted throughout a lobe attempt to achievemechanical volume reduction. However, such bending and folding of theairways increases resistance to gas flow which blocks the airways fromflowing efficiently to exchange gas. The bending also compresses tissueby permanently freezing motion in portions of the lung volume andpreventing those portions from efficiently contributing to exchanginggas. Thus, there is limited inspiration and expiration in those regionswhich reduces the patient's capacity to breathe. In addition, the coildesign and dimensions provide a very small contact area which produceshigh pressure and compressive stress on the lung tissue. Thispotentially allows for a kind of “cheese wire” cutting effect thatlimits the effective time that a treatment remains effective, even ifinitial results are positive. The coils are strong enough to bend thickcollagenous airways with substantial walls that would not be easilyabraded or subject to device related tissue erosion or migration.However, due to the nature of the disease and the enzymatic destructionin COPD patients, substantial, thick walled airways are nearly absentbeyond the 4th airway generation in patients with the requisite degreeof disease that would require this type of intervention. The typicaldisease related tissue destruction leaves only fragile segments of thintissue in areas in contact with the coils and this can only acceleratethe “cheese wire” effect which may reduce the potential for treatmentsuccess substantially. In addition, blood vessels run parallel to mostlung airways and they are of comparable size with respect to the airway.It is inadvisable to bend central airways (2nd-4th generation) as ablood vessel could easily be pinched closed or ruptured. Since thepatient's entire cardiac pumping capacity is routed through the lungsand these vessels, the use of such coils on these airways would presentthe patient with extreme risk.

Devices such as the endobronchial coils and endobronchial valves thatare mechanical structures suffer from fatigue related failure due to thehigh number of breathing cycles that these products endure and thenature of the flexure that lung airways present on these devices. Inorder to clear mucus, airways compress flat during coughing to reducethe cross-sectional area of the airway which increases the velocity ofexpelled gas and this increases the effectiveness of a cough event inclearing unwanted materials from the lung. In many cases, device failureoccurs where metallic or stiff biocompatible materials are placed in thelungs where coughing presents the devices with repeated high forceflexure and airway collapse. Another cause for device failure is tissueirritation and granular buildup of airway wall tissue and the formationof bacterial colonies that are commonly found on implanted polymers inthe lung. Most devices that have been previously proposed to treat COPDin the past have included one or more design flaws to cause granulationtissue formations or bacterial colonization's which are nearlyimpossible to remove or otherwise treat.

Thus, additional treatment options are desired, particularly fortreatment of homogenous COPD where LVRS is particularly ineffective andpotentially harmful. Such treatment options should avoid blocking off,rendering non-functioning or removing segments of the lung in the mannerof LVRS. In addition, such treatment options should avoid deleteriouscompression of tissue. Compression of lung tissue can compress and blockblood vessels leading to tissue necrosis and cell death, which in turncauses chronic air leaks and eventual lung collapse due to breaching ofthe vacuum seal between the lungs and chest wall. Such treatment optionsshould also be suitable for patients with late stage COPD. Thesepatients typically do not have any anatomically normal airways past the4^(th) generation where the anatomy is comprised of extremely weak,destroyed alveoli tissue which continues to degrade. The ideal solutionwill be a device made using materials and using methods that minimizesthe potential for bacterial colonization and the formation ofgranulation tissue in airways. At least some of these objectives will bemet by the present invention.

SUMMARY OF THE INVENTION

The present invention generally relates to medical systems, devices andmethods, and more particularly relates to treatment of patientssuffering from COPD. Likewise, the present invention relates to thefollowing numbered clauses:

In addition, the present invention relates to the following aspects:

In an aspect of the present invention, the pulmonary treatment devices,methods and systems contained herein treat COPD and COPD symptoms bytensioning lung tissue in patients who have been diagnosed withemphysema whereas lung tissue destruction has been determined to presentbetween zero and 70% volume of destroyed tissue, preferably at least 30%destruction, determined by calculating the percent of destroyed lowdensity lung volume tissue that presents in CT images with a Hounsfieldunit score at or higher than 850 (HU) Hounsfield units.

In another aspect of the present invention, the pulmonary treatmentdevices, methods and systems contained herein treat COPD and COPDsymptoms by tensioning lung tissue in patients who have been diagnosedwith emphysema whereas the patient has also been determined to betrapping air sufficiently so that retained residual volume is determinedto be between 100% and 400% of normal but most preferably residualvolume is determined to be in excess of 175% of normal for the patientsgender, age and height.

In another aspect of the present invention, the pulmonary treatmentdevices, methods and systems contained herein treat COPD and COPDsymptoms by tensioning lung tissue in patients who have been diagnosedwith emphysema whereas the treatment may be performed in each of thefour major lobes of the lungs, in a single or separate procedures, ifthe volume of damaged lung tissue in each lobe, defined as the volume oflow density tissue greater that 850 (HU), falls within a range of zeroto 70% but preferably is in excess of 30% in each lobe.

In another aspect of the present invention, the pulmonary treatmentdevices, methods and systems contained herein treat COPD and COPDsymptoms by compressing lung tissue as the tissue is wrapped around animplant device that has been fixed to lung tissue and torqued to berotated so lung tissue is drawn to the device and then anchored toanother portion of lung tissue, to prevent the implant fromcounter-rotating which would allow lung tissue to be unwound from theimplant.

In another aspect of the present invention, the pulmonary treatmentdevices, methods, systems and structures that may be considered implantsystems contained herein treat COPD and COPD symptoms by tensioning lungtissue and reducing lung volume to make at least one of the followingmeasurable physiologic changes to improve breathing in COPD patients:

1) Lift the diaphragm with respect to a reference rib location2) Measure diaphragm lift with respect to a reference rib location whilethe patient maintains expiration, as a result of treatment3) Elevate the base of at least one lung towards the patient's upperchest4) Reduce coughing5) Reduce mucus production6) Reduce coughing caused by trapped air and mucus7) Reduce glottis closure sensitivity8) Increase the patient's ability to clear mucus from the lungs9) Increase arterial blood oxygen levels in the blood stream10) Increase arterial blood oxygen percent in the blood stream11) Decrease arterial CO2 levels in the blood stream12) Decrease arterial CO2 percentage in the blood stream13) Increase mobility as measured by the currently standard 6-minutewalk test14) Increase the number of meters a patient can walk in 6 minutes15) Increase lung airway caliber as measured using high resolution CT16) Increase airway diameter17) Increase lung emptying volume during expiration18) Increase airway lumen diameter19) Provide radial outward support to airways20) Assist reduction of lung volume during exhalation21) Reduce the volume of at least one lung22) Reduce the volume of a lobe23) Reduce the volume of both lungs24) Reduce the volume of a lung pair25) Reduce TLC of a lung pair26) Perform tissue compression27) Compress tissue in a lobe28) Remove slack in the lung tissue29) Restore lung tissue elastic recoil back to a physiologic performancebetween 2 and 200 cm*H2O of pressure to expand the lung30) Increase lung elastic recoil31) Decrease lung compliance32) Change the shape of the pressure volume curve generated by measuringpatient breathing33) Increase the area within a pressure vs. volume curve describing apatient's breathing34) Displace fissures as seen using CT image post processed imagescomparing inspiration andexpiration data35) Delay airway closure during expiration, by using post processed CTimage data to compare pre-treatment versus post treatment airway volumesof a similar region in the lung36) Cause a volume of the lung to be reduced37) Reduce airway resistance38) Reduce the volume of one or more lungs in a patient39) Reduce inspiratory effort using pulse transit time or respiratoryinductance plethysmography methods40) Reduce dynamic hyperinflation as measured by CT or 6-minute walktesting or plethysmography41) Reduce end-expiratory lung volume42) Reduce functional residual capacity43) Reduce the incidence of respiratory failure44) Increase time between COPD exacerbation events45) Increase time that airways stay open during expiration46) Increase the forced expiratory volume in the first second (FEV1)47) Increase the forced vital capacity volume (FVC)48) Increase the ratio FEV1/FVC49) Reduce dysthymia50) Reduce pressure on the heart51) Reduce pressure on coronary arteries52) Reduce blood hypertension53) Reduce hypertension in the lungs54) Reduce hypertension in blood vessels that supply the heart muscle55) Reduce systolic and/or diastolic blood pressure56) Reduce heart rate57) Reduce systolic blood pressure58) Increase the heart's ejection fraction59) Reduce pulmonary artery pressure60) Reduce lung tissue density (from 800 to 810-1000 HU, that'sHounsfield units)61) Make lung tissue density more uniform (adjust the difference betweenlobes of average lobar density between 1-200 Hounsfield Units)62) Increase forced expiratory volume during expiration63) Reduce residual volume that is left in the lung during or afterexpiration (RV)64) Reduce the volume of gas that is trapped in the lung during or afterexpiration65) Reduce the volume of gas that is trapped in a lobe during or afterexpiration66) Increase tidal expiratory volume change during tidal breathing atrest67) Increase the inspiratory reserve volume during tidal breathing atrest68) Decrease the patient's breathing rate69) Decrease the patient's heart rate70) Increase the patient's cardiac blood ejection fraction71) Decrease the patient's total lung capacity72) Decrease lung compliance73) Decrease compliance in lobes or regions of lung tissue74) Increase lung tissue compliance uniformity between upper versuslower lobes75) Increase lung tissue compliance uniformity between lung lobes in apatient76) Increase lung tissue compliance uniformity between lobar segments77) Decrease inspiratory effort78) Decrease the total lung capacity (TLC)79) Reduce the RV/TLC ratio80) Increase the volume of airways in a lobe during inspiration81) Increase the volume of airways in a lobe during expiration82) Reduce the difference in volume of lung airways in a lobe duringbreathing83) Increase the total blood volume in a patient's lung or lobe byperforming a treatment84) Reduce regional blood volume in severely compromised lung tissue toreduce the volume of reduced oxygenated blood being mixed with normalblood in emphysema patients85) Increase the change in lobar volume between an inspiration andexpiration breathing cycle86) Reduce the volume of trapped air in a lobe after expiration87) Reduce expiratory volume of lungs after treatment88) Increase volume of one or more lobes during inspiration89) Increase the volume within distal airways in one or more lobes90) Increase the volume within central airways in one or more lobes91) Reduce impedance of central airways in one or more lobes92) Reduce impedance in one or both lungs93) Reduce resistance to flow in one or more lobes94) Reduce resistance to flow in one or more lungs95) Increase blood vessel density in one or more lobes96) Increase the number of blood vessels per liter of lobar volume97) Increase the volume of airway wall in one or more lobes98) Increase the volume of airway wall in central airways of one or morelobes99) Decrease the percentage of damaged tissue per liter of lung volumein one or more lobes100) Hold airways open longer to increase the rate of aerosol transportin one or more lobes101) Hold airways open longer to increase regional concentration ofaerosol delivered drugs in one or more lobes102) Measure one or more fissures that have moved more than 2 mm toindicate lobar volume has changed103) Measure one or more fissures that have moved with respect to achest wall rib more than 2 mm to indicate lung volume has changed104) Reduce the percentage of low attenuation lung tissue in one lobe ormore105) Reduce the volume of low attenuation lung tissue in one lobe ormore106) Reduce the percentage of low-density tissue that is 950 HU orhigher in one lobe or more107) Reduce the volume of low-density tissue that is 950 HU or higher inone lobe or more.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising: a distal end that efficiently attaches to lungtissue that has been degraded by enzymatic destruction.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising: a pulmonary treatment device with proximal adistal end that anchors to an airway in the lung.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising: a pulmonary treatment device with a distal endthat attaches to tissue primarily comprised of alveoli.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising: a treatment device, method or system thattensions lung tissue, parenchyma, alveoli, tissue with enzyme damage,distended, slackened or stretched tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising: a pulmonary treatment device that is producedfrom round wire shaft material that presents minimal sharp edges to softtissues in the lung, that would otherwise cause the formulation ofgranulation tissue

In another aspect of the present invention, a COPD treatment device isprovided comprising: a lung treatment device that is produced from roundwire shaft material with a distal end and a proximal end, whereas atleast the distal or proximal end is formed to make a blunt atraumaticend without the benefit of recasting material.

In another aspect of the present invention, a COPD treatment device isprovided comprising: a lung treatment device that is produced from roundwire shaft material with a distal end, a proximal end and a midsectionwhereas the distal end is connected to the midsection and the proximalend is connected to the midsection without the benefit of a connectionto join components.

In another aspect of the present invention, a COPD treatment device isprovided comprising: a lung treatment device that is produced and coatedwith an anti-bacterial coating such as silver or some other materialthat bacteria is repelled from.

In one aspect of the present invention, a pulmonary treatment device isprovided comprising: an elongate shaft coiled into a helical shapearound a longitudinal axis to form a tissue gathering end, an extendablemidsection and a stabilizing end, wherein the tissue gathering endincludes at least one loop which curves at least partially around thelongitudinal axis and is configured to engage loose damaged alveolar sactissue, wherein the stabilizing end includes at least one loop whichcurves at least partially around the longitudinal axis and is configuredto engage a lung passageway proximal to the loose damaged alveolar sactissue, and wherein the extendable midsection is configured to extendalong the longitudinal axis while the tissue gathering end engages theloose damaged alveolar sac tissue so that the loose damaged alveolar sactissue is pulled toward the lung passageway and the stabilizing endseats in the lung passageway in a manner that maintains the loosedamaged alveolar sac tissue in a pulled position.

In another aspect of the present invention, a device is provided fortreating a lung comprising: a tissue engaging end configured to engageloose damaged alveolar sac tissue; and a stabilizing end configured toengage a lung passageway proximal to the loose damaged alveolar sactissue, wherein the device is configured to re-tension a portion of thelung by pulling the tissue engaging end toward the stabilizing endseated in the lung passageway and maintaining such pulling by recoilforce.

In another aspect of the present invention, a lung treatment device isprovided for treating a lung; comprising a tissue gathering distal end,a stabilizing proximal end and an elastic midsection whereas at least aportion of the device is configured to be positioned around the exteriorof a bronchoscope in a configuration that is suitable for advancementinto the lung. The device is configured so that at least a portion ofthe tissue gathering end or a portion of the mid-section or a portion ofthe stabilizing end is configured to circle at least partially aroundthe longitudinal axis of the bronchoscope during advancement into thelung and is configured to displace lung tissue, wherein the extendablemidsection is configured to be lengthened while the tissue gathering endis anchored to lung tissue in a way that allows lung tissue to be pulledtoward the midsection of the device and the stabilizing end seats inlung tissue in a manner so lung tissue at the proximal end of thetreatment device is pulled towards the midsection of the treatmentdevice, after the bronchoscope is removed from the lung.

In another aspect of the present invention, a lung treatment device isprovided for treating a lung comprising: a tissue gathering endconfigured to be fixed to lung tissue; a stabilizing proximal endconfigured to be fixed to lung tissue that is proximal to the tissue thetissue gathering end is fixed to, wherein the device is configured tore-tension a portion of the lung by pulling the tissue gathering endtowards the stabilizing end seated in the lung.

In another aspect of the present invention, a lung treatment device isprovided for treating a lung comprising: a tissue gathering endconfigured to be fixed to lung tissue; a stabilizing proximal endconfigured to be fixed to lung tissue that is proximal to the tissue thetissue gathering end is fixed to, wherein the device is configured tore-tension a portion of the lung by pulling the tissue that the tissuegathering end is fixed to toward the tissue that the stabilizing end isfixed to in the lung.

In another aspect of the present invention, a pulmonary treatment deviceis provided for treating a lung comprising: a tissue gathering endconfigured to be fixed to lung tissue; a stabilizing proximal endconfigured to be fixed to lung tissue that is proximal to the tissue thetissue gathering end is fixed to, wherein the device is configured tore-tension a portion of the lung by pulling the tissue that the tissueengaging end is fixed to toward the tissue that the stabilizing end isfixed to in the lung while the midsection of the lung treatment deviceis configured to maintain a patent lumen through the lung treatmentdevice.

In another aspect of the present invention, a lung treatment device isprovided for treating a lung comprising: a tissue gathering endconfigured to be fixed to lung tissue; a stabilizing proximal endconfigured to be fixed to lung tissue that is proximal to the tissue thetissue gathering end is fixed to, wherein the device is configured to beadvanced into the lung and then stretched to a longer configurationbefore fixing the tissue gathering end to tissue and before fixing theproximal stabilizing end to tissue to more effectively re-tension aportion of the lung by pulling the tissue engaging end towards thestabilizing end which is fixed to tissue in the lung.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising: an elongate shaft coiled into a helical shapearound a longitudinal axis to form a tissue gathering end, an extendablemidsection and a stabilizing end, wherein the tissue gathering endincludes at least one loop that is configured to engage loose damagedalveolar sac tissue or the wall of an airway, wherein the stabilizingend includes at least one loop which curves at least partially aroundthe longitudinal axis and is configured to engage a lung passagewayproximal to the loose damaged alveolar sac tissue, and wherein theextendable midsection is configured to extend along the longitudinalaxis while the tissue gathering end engages the loose damaged alveolarsac tissue so that the loose damaged alveolar sac tissue is pulledtoward the lung passageway and the stabilizing end seats in the lungpassageway in a manner that maintains the loose damaged alveolar sactissue in a pulled position.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising: an implant made from polymer or metal thatbehaves in at least a partially elastic manor that is shaped to form atissue gathering anchor end, an extendable midsection and a stabilizingend, wherein the tissue gathering end can be advanced distally to causethe extendable midsection to be extended with increased length andstrained elastically after which the tissue gathering end may bedeployed to be fixed or anchored to the wall of the airway, wherein thestabilizing end includes at least one loop which curves at leastpartially around the longitudinal axis and is configured to engage alung passageway proximal to the midsection, and wherein the extendablemidsection is configured to provide elastic recoil force that tensionslung tissue and provides lumen patency maintaining support to stent theairway and prevent airway collapse while the tissue gathering end andthe proximal stabilizing ends are pulled towards each other.

In another aspect of the present invention, a pulmonary treatment deviceis provided that reduces the length of airway segments to enhance lungelastic recoil.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is configured to be mounted to the outside of abronchoscope while it is delivered to a location in the lung.

In another aspect of the present invention, a pulmonary treatment deviceis provided that configured to be advanced into the lung in a lengthunconstrained configuration. This allows the system to be flexible whilebeing delivered along a tortuous path. Most of these devices aredelivered to the upper lobes and that typically requires the scope anddevice to go through at least one small radius bend in the lungs.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be advanced into the lung in a condition that isunstressed to allow the delivery system to be flexible while the deviceis being delivered along a tortuous path.

In another aspect of the present invention, a pulmonary treatment deviceis provided for treating a lung that has not been stressed to lengthenor shorten the device length so as to allow the delivery system to be asflexible as possible while being delivered along a tortuous path.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is configured so that the length can be lengthened orshorted before deploying the device into the lung to stress lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be advanced along a tortuous path to a treatmentlocation in the lung and configured in a flexible unstressed conditionthat allows the length to be unconstrained but configured to beelongated at the treatment location before being deployed to distortlung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be advanced along a tortuous path to a treatmentlocation in the lung, configured in a flexible unstressed condition, butconfigured to be strained to a longer configuration to store strainenergy that may be applied to lung tissue after deployment of thetreatment device.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be advanced into the lung and the device length canbe adjusted to change length after a portion of the device is placed incontact with lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and springcoil midsection.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a central lumen and a constrained distal anchorfeature that is unconstrained by retracting a delivery device componentfrom the central lumen of the treatment device.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a central longitudinal axis, a distal end, aproximal end and a lumen running coaxial along the central longitudinalaxis that is configured to be guided by a guidewire that is advancedthrough the lumen along the central longitudinal axis.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a central longitudinal axis, a distal end, aproximal end and a lumen running coaxial along the central longitudinalaxis that is configured to be guided by a bronchoscope that is advancedthrough the lumen along the central longitudinal axis.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising distal and proximal anchors and a midsection thatcan be elongated to store fully elastic strain energy in the midsection.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising distal and proximal anchors and a midsection thatcan be elongated to store fully elastic strain energy in the treatmentdevice before the device is coupled to lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a tissue gathering distal end, a stabilizingproximal end and a midsection that can be elongated to store fullyelastic strain energy.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a tissue gathering distal end, a stabilizingproximal end and a midsection that can be elongated to store fullyelastic strain energy before the device is coupled to lung tissue so thedevice causes length compression of the lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a tissue gathering distal end, a stabilizingproximal end and a midsection that can be elongated to store fullyelastic strain energy after the stabilizing proximal end is seated inlung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal end, a proximal end and a midsectionthat can be elongated to store fully elastic strain energy that can bedeployed in a lung to restore tension in lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal end, a proximal end and a midsectionthat can be elongated to store fully elastic strain energy that can bedeployed in a lung to restore lung elastic recoil in the lung.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a proximal end, a distal end and a midsectionconfigured such that the midsection is cylindrical and the proximal endis flared.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a proximal end, a distal end and a midsectionconfigured such that the midsection is tapered so the diameter variesalong the length of the midsection of the device.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a proximal end, a distal end and a midsectionconfigured such that the distal end comprises a spring element that canbe constrained by the exterior surfaces of a bronchoscope.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a proximal end, a distal end and a midsectionconfigured such that the device comprises a spring element that can beexpanded to a larger diameter by a balloon.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is configured to be mounted around the outside of abronchoscope while it is delivered to a location in the lung to increasetension in lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided having a distal anchor, a proximal anchor and a midsectionthat can be elongated to store elastic strain energy to tension lungtissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be advanced into the lung in a condition that isunstressed to allow the system to be flexible while being deliveredalong a tortuous path, configured with a distal anchor, a proximalanchor and a midsection that is made from single wire shaft.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection that is made from continuous wire shaft.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection that is made from single element with no connections to joinfeatures of the device.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection; the treatment device is configured in a way that may beelongated to store elastic strain energy to tension lung tissuecomprising at least one weldment to connect features of the device.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection; the treatment device is configured in a way that may beelongated to store elastic strain energy to tension lung tissuecomprising at least one crimped sleeve to connect features of thedevice.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection; the treatment device is configured in a way that may beelongated to store elastic strain energy to tension lung tissuecomprising at least one glue bonded joint to connect features of thedevice.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is made from a continuous wire shaft whereas the wireshaft ends are terminated to be blunt atraumatic tips.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is made from a continuous wire shaft whereas at leastone wire shaft end is recast to be shaped into a blunt atraumatic bluntend.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is made from a continuous wire shaft that may bedelivered while at least partially encircling a bronchoscope and atleast one wire shaft end is recast to be shaped into a ball shaped tip.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal end, a proximal end and a midsection;the treatment device is made from one or more wire shaft components andat least one proximal end or one distal end or both ends are recast tobe shaped into ball shaped blunt tip.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal end, a proximal end and a midsection;the treatment device is configured to be delivered at least partiallymounted to the outside of a bronchoscope and at least one proximal endor one distal end or both ends are recast to be shaped into ball shapedblunt tips.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection; the treatment device is configured in a way that may beelongated to store elastic strain energy to tension lung tissue whereasthe distal end has been melted to form a blunt ball end.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is configured in a way that may be elongated to storeelastic strain energy to tension lung tissue whereas the distal end hasbeen melted to form a blunt ball end.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection; the treatment device is configured in a way that may beelongated to store elastic strain energy to tension lung tissue whereasthe distal end has been melted to form a blunt end.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is configured in a way that may be elongated to storeelastic strain energy to tension lung tissue whereas the distal end hasbeen melted to form a blunt end.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection; the treatment device is configured in a way that may beelongated to store elastic strain energy to tension lung tissue whereasthe distal end has had material joined to it to form an atraumatic end.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is configured in a way that may be elongated to storeelastic strain energy to tension lung tissue whereas the distal end hashad material joined to it to form an atraumatic end.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection; the device being configured so it can be advanced into thelung in a delivery configuration that has not been stressed to lengthenor shorten the device length and the device is configured in such a waythat the device may be elongated to store elastic strain energy andanchored to lung tissue such that lung tissue is tensioned in adelivered treatment configuration.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection that may be delivered to a treatment site in a deliveryconfiguration and made to perform work on lung tissue in a treatmentconfiguration. In the delivery configuration, the device may be advancedinto the lung free from stress that would otherwise lengthen or shortenthe device; in the treatment configuration the device may be elongatedto store elastic strain energy to beneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection; the device being configured so it can be elongated to storeelastic strain energy whereby the distal anchor is anchored to alocation in a lung, the proximal anchor is anchored in a proximallocation in the lung that is distant from the location of the distalanchor and the elastic strain energy is allowed to reduce the distancebetween the distal anchor and the proximal anchor to bring the distaland proximal anchors closer together in the lung.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection that may be delivered to a treatment site in a deliveryconfiguration and made to perform work on lung tissue in a treatmentconfiguration. In the delivery configuration, the device may beelongated to store elastic strain energy; in the treatment configurationthe device may use the elastic strain energy to shorten the device tobeneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection that may be delivered to a treatment site in a deliveryconfiguration and made to perform work on lung tissue in a treatmentconfiguration. In the delivery configuration, the device may be mountedaround the exterior of a bronchoscope; in the treatment configurationthe device may benefit by the use of pneumatic pressure to shorten thedevice to beneficially tension lung tissue. Shortening may beaccomplished by pneumatically expanding the device diameter, using aballoon, while allowing device foreshortening to shorten the device tocause lung tissue tensioning.

In another aspect of the present invention, a pulmonary treatment deviceis provided comprising a distal anchor, a proximal anchor and amidsection that may be delivered to a treatment site in a deliveryconfiguration and made to perform work on lung tissue in a treatmentconfiguration. In the delivery configuration, the device may be mountedaround the exterior of a bronchoscope; in the treatment configurationthe device may benefit by the use of hydraulic pressure to shorten thedevice to beneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be advanced along a tortuous path to a treatmentlocation in the lung, configured in a flexible unstressed condition thatallows the length to be unchanged from its unstressed state, butconfigured to be elongated at the treatment location before beingdeployed to distort lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be advanced along a tortuous path to a treatmentlocation in the lung, configured in a flexible condition whereas thelength is unchanged from its unstressed state, but configured to beelongated at the treatment location before being deployed to distortlung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be advanced along a tortuous path to a treatmentlocation in the lung, configured in a flexible condition whereas thelength is unchanged from its unstressed state but configured to shortenin an unassisted way, after being deployed in tissue, to beneficiallytension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be advanced along a tortuous path to a treatmentlocation in the lung, configured in a flexible condition configured toshorten in an unassisted way, after being deployed in tissue, tobeneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a distal end, a proximal end and amidsection that can be advanced along a tortuous path to a treatmentlocation in the lung, configured to shorten in an unassisted way, afterbeing deployed in tissue, to beneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a distal end, a proximal end and amidsection that can be advanced along a tortuous path to a treatmentlocation in the lung, configured to shorten in an unassisted way, afterbeing elongated to store elastic strain energy, to beneficially tensionlung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a distal anchor, a proximal anchor and amidsection that can be advanced along a tortuous path to a treatmentlocation in the lung, configured to shorten in an unassisted way, afterbeing elongated to store elastic strain energy, to beneficially tensionlung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a distal anchor that anchors a firstlocation in a lung, a proximal anchor that anchors a second location ina lung that is distant to the first location and a midsection, connectedto the proximal and distal anchors; the device is configured so it canbe advanced along a tortuous path to a treatment location in the lung,the midsection is configured to be lengthened before the proximal anddistal anchors are deployed to beneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a distal anchor that anchors a firstlocation in a lung, a proximal anchor that anchors a second location ina lung that is distant to the first location and a midsection, connectedto the proximal and distal anchors; the device is configured so it canbe advanced along a tortuous path to a treatment location in the lung,the midsection is configured to shorten after the proximal and distalanchors are deployed, to beneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a distal anchor that anchors a firstlocation in a lung, a proximal anchor that anchors a second location ina lung that is distant to the first location and a midsection, connectedto the proximal and distal anchors; the device is configured to bemounted at least partially around the outside of a bronchoscope so itcan be advanced along a tortuous path to a treatment location in thelung, the midsection is configured to shorten after the proximal anddistal anchors are deployed, to beneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a distal anchor that anchors a firstlocation in a lung, a proximal anchor that anchors a second location ina lung that is distant to the first location and a midsection, connectedto the proximal and distal anchors; the device is configured to bemounted at least partially around the outside of a bronchoscope so itcan be advanced along a tortuous path to a treatment location in thelung, the midsection is configured to shorten after the proximal anddistal anchors are deployed, to beneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a distal anchor that anchors a firstlocation in a lung, a proximal anchor that anchors a second location ina lung that is distant to the first location and a midsection, connectedto the proximal and distal anchors; the device is configured to bemounted at least partially around the outside of a bronchoscope so itcan be advanced along a tortuous path to a treatment location in thelung, the midsection is configured to be shortened after the proximaland distal anchors are deployed, to beneficially tension lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided that acts in a stent-like manner to maintain lung airwaypatency and straighten the airway path between its proximal and distalends.

In another aspect of the present invention, a pulmonary treatment deviceis provided that acts in a stent-like manner that supports the airway toopen the airway lumen and also to act as a tensioning device along thelongitudinal axis of the airway.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is advanceable into the lung in a non-strained state.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is advanceable into the lung while maintaining anunstretched length.

In another aspect of the present invention, a pulmonary treatment deviceis provided that at least partially encircles the bronchoscope used todeliver the pulmonary treatment device.

In another aspect of the present invention, a pulmonary treatment deviceis provided with a distal anchor feature, configured to beneficially usea bronchoscope shaft to hold the distal anchor from being deployed whilethe device is being advanced into the lung.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to encircle the bronchoscope so the scope shaftstrength is used to beneficially modify the treatment device dimensions.

In another aspect of the present invention, a pulmonary treatment deviceis provided that may be lengthened by advancing the bronchoscope.

In another aspect of the present invention, a pulmonary treatment deviceis provided that may be elongated by advancing the bronchoscope.

In another aspect of the present invention, a pulmonary treatment deviceis provided that may be elongated by retracting the bronchoscope.

In another aspect of the present invention, a pulmonary treatment deviceis provided that may be elongated by retracting a bronchoscope guidesleeve.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to deploy the proximal end to engage tissuefirst before being lengthened to enhance lung elastic recoil.

In another aspect of the present invention, a pulmonary treatment deviceis provided that may be advanced into the lung in a state whereby thedevice has not been strained to be lengthened or shortened from azero-strain length, whereby the device length may be increased, usingdelivery system components at the treatment site before any portion ofthe device is released from the delivery system.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be pulled and lengthened after partial deployment.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be pulled and lengthened after deploying its distalend.

In another aspect of the present invention, a pulmonary treatment deviceis provided that may be tensioned along the longitudinal direction butthe device length is maintained after deploying the distal end.

In another aspect of the present invention, a pulmonary treatment deviceis provided that can be longitudinally tensioned to pull distal end andadjacent lung tissue more proximally after deploying the distal end.

In another aspect of the present invention, a pulmonary treatment deviceis provided with flared ends for treating emphysema (end diameter islarger than midsection).

In another aspect of the present invention, a pulmonary treatment deviceis provided that acts in a stent-like manner with flared ends fortreating emphysema (end diameter is larger than central body).

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue that can be deployed in everyanatomical lumen in lung that is either anatomical or made by disease orcreated by a device as shown as RB through LB10 on conventional airwaycharts.

In another aspect of the present invention, a pulmonary treatment deviceis provided that acts in a stent-like manner that is delivered byadvancing a bronchoscope.

In another aspect of the present invention, a pulmonary treatment deviceis provided that stents lung tissue that is delivered by advancing acatheter (without the use of a scope).

In another aspect of the present invention, a pulmonary treatment deviceis provided to stent lung tissue wherein the device is delivered byguiding a bronchoscope in position using a guidewire.

In another aspect of the present invention, a pulmonary treatment deviceis provided to stent lung tissue wherein the device is delivered byguiding a catheter in position using a guidewire.

In another aspect of the present invention, a pulmonary treatment deviceis provided that straightens airways.

In another aspect of the present invention, a pulmonary treatment deviceis provided that straightens 2 or more airways at the same time.

In another aspect of the present invention, a pulmonary treatment deviceis provided that straightens 2 or more airways while laterally urgingthem closer together.

In another aspect of the present invention, a pulmonary treatment deviceis provided that urges 2 or more airways together to cause lung tissuetension.

In another aspect of the present invention, a pulmonary treatment deviceis provided that urges 2 or more airways together to cause any one ofthe beneficial changes listed above as items (1) through (107) above.

In another aspect of the present invention, a pulmonary treatment deviceis provided that straightens an airway while shortening the length ofthe airway.

In another aspect of the present invention, a pulmonary treatment deviceis provided that displaces lung tissue closer to the trachea.

In another aspect of the present invention, a pulmonary treatment deviceis provided that pulls tissue farther from the pleura.

In another aspect of the present invention, a pulmonary treatment deviceis provided that shifts lung tissue closer to the heart.

In another aspect of the present invention, a pulmonary treatment deviceis provided that urges 2 or more airways together to displaces lungtissue closer to the trachea. In another aspect of the presentinvention, a pulmonary treatment device is provided that urges 2 or moreairways together to pull tissue farther from the pleura.

In another aspect of the present invention, a pulmonary treatment deviceis provided that urges 2 or more airways together to shift lung tissuecloser to the heart.

In another aspect of the present invention, a pulmonary treatment deviceis provided that shortens an airway length while tensioning tissue thatis distal to its distal end.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is tensioned while supporting airway patency.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is tensioned while supporting airway patency betweenits ends.

In another aspect of the present invention, a pulmonary treatment deviceis provided that stents lung tissue to provide support to keep airwaysopen while also providing tension in the longitudinal axis of theairway.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is resilient enough to change dimension duringbreathing

In another aspect of the present invention, a pulmonary treatment deviceis provided, comprising a curvilinear shape that maintains a fixedlength as measured down the curvilinear path before and afterdeployment, that tensions lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided that straightens an airway while allowing gas to flowthrough in at least one direction.

In another aspect of the present invention, a pulmonary treatment deviceis provided that deploys into an airway while the device alsostraightens the gas flow path through the airway where the pulmonarytreatment device is deployed.

In another aspect of the present invention, a pulmonary treatment deviceis provided, comprising a distal end designed to couple to low densitylung tissue that is known to be greater than 800 HU in density.

In another aspect of the present invention, a pulmonary treatment deviceis provided, comprising an optimized design with high tissue contactarea to reduce lung tissue stress,

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue distal to the pulmonary treatmentdevice and shortens the length of the airway the pulmonary treatmentdevice occupies.

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue distal to the pulmonary treatmentdevice and shortens the length of the airway the pulmonary treatmentdevice occupies and supports the airway wall to maintain airway patency.

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue distal to the pulmonary treatmentdevice whereas the device length is increased as tension is applied tothe device.

In another aspect of the present invention, a pulmonary treatment deviceis provided, comprising an anchor that tensions lung tissue whereas thedevice length is increased as the proximal end of the device is movedcloser to the trachea.

In another aspect of the present invention, a pulmonary treatment deviceis provided, comprising an anchor that tensions lung tissue whereas thedevice length is increased as a portion of the device is moved closer tothe trachea.

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue longitudinally along the axis thedevice occupies while also supporting the airway wall to maintain airwaypatency.

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue and reduces elastic recoiladjacent the airway that the pulmonary treatment device occupies.

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue distal or proximal to thepulmonary treatment device and supports the airway wall to maintainairway patency.

In another aspect of the present invention, a pulmonary treatment deviceis provided that straightens at least a portion of airway wall.

In another aspect of the present invention, a tensioning pulmonarytreatment device is provided, comprising at least one end that forms acircular shape.

In another aspect of the present invention, a tensioning pulmonarytreatment device is provided, comprising at least one end that forms ahelical shape.

In another aspect of the present invention, a tensioning pulmonarytreatment device is provided, comprising at least one end thatpenetrates lung tissue.

In another aspect of the present invention, a tensioning pulmonarytreatment device is provided, comprising at least one end that deploysin a shape that contacts itself.

In another aspect of the present invention, a tensioning pulmonarytreatment device is provided, comprising at least one end that does notcompress tissue.

In another aspect of the present invention, a tensioning pulmonarytreatment device is provided, comprising a design which is axisymmetric.

In another aspect of the present invention, a tensioning pulmonarytreatment device is provided that changes the lung volume sufficientlyto move the heart laterally.

In another aspect of the present invention, a pulmonary treatment deviceis provided that stents lung tissue to hold at least a portion of anairway lumen open while providing longitudinal tension.

In another aspect of the present invention, a pulmonary treatment deviceis provided, comprising a proximal or distal end that straightens astension is applied to the device during deployment.

In another aspect of the present invention, a lung tissue tensioningpulmonary treatment device is provided that does not compress tissue.

In another aspect of the present invention, a lung tissue tensioningpulmonary treatment device is provided that selectively tensions tissueregions.

In another aspect of the present invention, a lung tissue tensioningpulmonary treatment device is provided that increases tension in lungtissue to a uniform magnitude.

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue in a portion of a lung whilerelieving tension in another portion of the same lung.

In another aspect of the present invention, a pulmonary treatment deviceis provided that is delivered in a delivery configuration and deployedin a deployed configuration, comprising a proximal end; a distal end anda midsection which is connected to the proximal end and the distal end;configured to a delivery length in a delivery configuration and adeployed length that is longer than the delivery length.

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue in a way that is compliant duringbreathing

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue and elongates during theinspiration portion of the breathing cycle.

In another aspect of the present invention, a pulmonary treatment deviceis provided that tensions lung tissue and contracts to a shorter lengthduring the expiration portion of the breathing cycle.

In another aspect of the present invention, a COPD treatment device isprovided that lengthens during the inspiration portion of the breathingcycle.

In another aspect of the present invention, a COPD treatment device isprovided that shortens during the exhalation portion of the breathingcycle.

In another aspect of the present invention, a COPD treatment device isprovided that acts as a stent device, comprising: a tubular shapedmember having first and second open end and a lumen runningtherethrough, said member is sized for placement within a lung airway,said member is comprised of a shape memory material that exhibits ashape recovery transition temperature in a temperature range belownormal body temperature such that after placement within the lung,having a temperature at or near normal body temperature, said memberexpands radially and contracts longitudinally so at least a portion ofsaid member becomes firmly anchored to lung tissue.

In another aspect of the present invention, a COPD treatment device isprovided that acts as a stent device, comprising: a tubular shapedmember having first and second open end and a lumen runningtherethrough, said member is sized for placement within a lung airway,said member is comprised of a shape memory material that exhibits ashape recovery transition temperature in a temperature range belownormal body temperature such that after placement within the lung,having a temperature at or near normal body temperature, said memberexpands radially and contracts longitudinally so at least a portion ofsaid member straightens the lung airway.

In another aspect of the present invention, a COPD treatment device isprovided comprising a helically wound coil spring, wherein the springhas a tubular shaped member having first and second open end and a lumenrunning therethrough, said member sized for placement within a lungairway, said member comprised of a shape memory material that exhibits ashape recovery transition temperature in a temperature range belownormal body temperature such that after placement within the lung,having a temperature at or near normal body temperature, said memberexpands radially and contracts longitudinally so at least a portion ofsaid member straightens the lung airway.

In another aspect of the present invention, a COPD treatment device isprovided that acts as a stent device, comprising: a tubular shapedmember having first and second open end and a lumen runningtherethrough, said member is sized for placement within a lung airway,said member is comprised of a shape memory material that exhibits ashape recovery transition temperature in a temperature range belownormal body temperature such that after placement within the lung,having a temperature at or near normal body temperature, said memberexpands radially and contracts longitudinally so at least a portion ofsaid member tensions the lung tissue.

In another aspect of the present invention, a COPD treatment device isprovided that acts as a helically wound coil spring, comprising: atubular shaped member having first and second open end and a lumenrunning therethrough, said member is sized for placement within a lungairway, said member is comprised of a shape memory material thatexhibits a shape recovery transition temperature in a temperature rangebelow normal body temperature such that after placement within the lung,having a temperature at or near normal body temperature, said memberexpands radially and contracts longitudinally so at least a portion ofsaid member tensions lung tissue.

In another aspect of the present invention, a COPD treatment device isprovided that acts as a stent device, comprising: a tubular shapedmember having first and second open end and a lumen runningtherethrough, said member is sized for placement within a lung airway,said member is comprised of a nitinol material that exhibits a shaperecovery transition temperature in a temperature range below normal bodytemperature such that after placement within the lung, having atemperature at or near normal body temperature, said member expandsradially and contracts longitudinally so at least a portion of saidmember tensions the lung tissue.

In another aspect of the present invention, a COPD treatment device isprovided that acts as a helically wound coil spring, comprising: atubular shaped member having first and second open end and a lumenrunning therethrough, said member is sized for placement within a lungairway, said member is comprised of nitinol material that exhibits ashape recovery transition temperature in a temperature range belownormal body temperature such that after placement within the lung,having a temperature at or near normal body temperature, said memberexpands radially and contracts longitudinally so at least a portion ofsaid member tensions lung tissue.

In another aspect of the present invention, a COPD treatment device isprovided that acts as a stent device, comprising a proximal end, adistal end and a midsection that joins the ends and a lumen runningtherethrough, said member is sized for placement within a lung airway,said member is comprised of a nitinol material that exhibits a shaperecovery transition temperature in a temperature range below normal bodytemperature such that after placement within the lung, having atemperature at or near normal body temperature, said member contractslongitudinally so at least a portion of said member tensions the lungtissue.

In another aspect of the present invention, a COPD treatment device isprovided that acts as a stent device, comprising a proximal end, adistal end and a midsection that joins the ends and a lumen runningtherethrough, said member is sized for placement within a lung airway,said member is comprised of a nitinol material that exhibits a shaperecovery transition temperature in a temperature range below normal bodytemperature such that after placement within the lung, having atemperature at or near normal body temperature, said member contractslongitudinally so at least a portion of said member tensions the lungtissue; whereas the distal end is configured to anchor to loose lungtissue.

In another aspect of the present invention, a COPD treatment device isprovided comprising a helically wound coil spring, comprising: a tubularshaped member having first and second open end and a lumen runningtherethrough, said member is sized for placement within a lung airway,said member is comprised of nitinol material that exhibits a shaperecovery transition temperature in a temperature range below normal bodytemperature such that after placement within the lung, having atemperature at or near normal body temperature, said member contractslongitudinally so at least a portion of said member tensions lungtissue.

In another aspect of the present invention, a COPD treatment device isprovided comprising a helically wound coil spring, comprising: a tubularshaped member having first and second open end and a lumen runningtherethrough, said member is sized for placement within a lung airway,said member is comprised of nitinol material that exhibits a shaperecovery transition temperature in a temperature range below normal bodytemperature such that after placement within the lung, having atemperature at or near normal body temperature, said member contractslongitudinally so at least a portion of said member tensions lungtissue; whereas the distal end is configured to anchor in loose lungtissue.

In another aspect of the present invention, a COPD treatment device isprovided comprising a helically wound coil spring, comprising: a tubularshaped member having first and second open end and a lumen runningtherethrough, said member is sized for placement within a lung airway,said member is comprised of nitinol material that exhibits a shaperecovery transition temperature in a temperature range below normal bodytemperature such that after placement within the lung, having atemperature at or near normal body temperature, said member contractslongitudinally so at least a portion of said member tensions lungtissue; whereas the proximal end is configured to anchor in reinforcedlung tissue.

In another aspect of the present invention, a COPD treatment device isprovided comprising a first coil shaped end and second coil shaped endand a lumen running therethrough, said device is sized for placementwithin a lung airway, said device is comprised of nitinol material thatexhibits a shape recovery transition temperature in a temperature rangebelow normal body temperature such that after placement within the lung,having a temperature at or near normal body temperature, said devicecontracts longitudinally so at least a portion of said device tensionslung tissue.

In another aspect of the present invention, a COPD treatment device isprovided that straightens the airway comprising a single helicalcomponent with an arc length that is not changed during deployment.

In another aspect of the present invention, a COPD treatment device isprovided that does not cause lung volume reduction.

In another aspect of the present invention, a COPD treatment device isprovided that causes minimal lung volume reduction.

In another aspect of the present invention, a COPD treatment device isprovided that does not cause lung volume compression.

In another aspect of the present invention, a COPD treatment device isprovided that causes minimal lung volume compression.

In another aspect of the present invention, a COPD treatment device isprovided that does not cause lung tissue compression.

In another aspect of the present invention, a COPD treatment device isprovided that causes minimal lung tissue compression.

In another aspect of the present invention, a COPD treatment device isprovided comprising: a resilient stent device for straightening lungairways comprising a wire formed into a plurality of bends to generallyform a helical shape having a longitudinal axis that is lengthenedbefore being decoupled from a delivery system to apply longitudinaltension to lung tissue in a patient when said stent device is disposedwithin said airway.

In another aspect of the present invention, a COPD treatment device isprovided comprising: a medical device for straightening a lung airway,comprising: a tissue gathering end, a stabilizing end, and a tetherextending between the tissue gathering end and stabilizing end, thedevice configured so that the distance between the ends measured alongthe tether is fixed and maintained after being released from a deliverydevice but the distance between the ends can be lengthened by moving thedelivery device before releasing the medical device from the deliverydevice.

In another aspect of the present invention, a COPD treatment device isprovided that tensions lung tissue and a tension indicator feature.

In another aspect of the present invention, a COPD treatment device isprovided that tensions lung tissue and a displacement indicator feature.

In another aspect of the present invention, a COPD treatment device isprovided that straightens airways in the lung that includes a tensionindicator feature.

In another aspect of the present invention, a COPD treatment device isprovided that straightens airways in the lung and includes adisplacement indicator feature.

In another aspect of the present invention, a COPD treatment device isprovided that straightens airways in the lung when tension is applied tothe lung tissue.

In another aspect of the present invention, a COPD treatment device isprovided that dilates airways in the lung when the device is used toapply tension to lung tissue.

In another aspect of the present invention, a COPD treatment device isprovided comprising: a medical device for straightening a lung airway,comprising: a tissue gathering end, a stabilizing end, and a tetherextending between the tissue gathering end and stabilizing end, whereasthe tether is shaped to form a coil and the coil is straightened as thedistance between the tissue gathering end and the stabilizing end of thedevice is lengthened.

In another aspect of the present invention, a COPD treatment device isprovided comprising: a medical device used to tension lung tissue;having a tissue gathering end, a stabilizing end and a tether joiningthe two ends that is made from a single continuous length of plastic,metal, tubing, wire, or extrusion.

In another aspect of the present invention, a COPD treatment device isprovided comprising: a first portion having a first bearing surface anddefining a first local axis, the first portion of the treatment deviceconfigured to engage a first portion of the airway with the firstbearing surface; and the treatment device further comprising a secondportion coupled to the first portion of the treatment device, the secondportion of the treatment device having a second bearing surface anddefining a second local axis, the second portion of the treatment deviceconfigured to engage a second portion of the airway with the secondbearing surface, the second portion of the airway being axially spacedapart from the first portion of the airway; wherein, in a deployedconfiguration within the lung, the first portion of the treatment devicepresses against the first portion of the airway to urge it to a morecoaxial orientation relative to the second local axis, and the secondportion of the treatment device presses against the second portion ofthe airway to urge it to a more coaxial orientation relative to thefirst local axis, thereby straightening the path through the airway incontact with the first and second portions of the treatment device.

In another aspect of the present invention, a COPD treatment device isprovided comprising: a first portion having a structure with a centroiddefining a first local axis and a first bearing surface, the firstportion of the treatment device configured to engage a first portion ofthe airway with the first bearing surface; and the treatment devicefurther comprising a second portion coupled to the first portion of thetreatment device, the second portion of the treatment device having astructure with a centroid defining a second local axis and a secondbearing surface, the second portion of the treatment device configuredto engage a second portion of the airway with the second bearingsurface, the second portion of the airway being axially spaced apartfrom the first portion of the airway; wherein, in a deployedconfiguration within the lung, the first portion of the treatment devicepresses against the first portion of the airway to urge it to a morecoaxial orientation relative to the second local axis, and the secondportion of the treatment device presses against the second portion ofthe airway to urge it to a more coaxial orientation relative to thefirst local axis, thereby straightening the path through the airway incontact with the first and second portions of the treatment device

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within an airway of a lung of apatient for treating the lung of the patient, the treatment devicecomprising: a first portion having a structure with a centroid defininga first local axis and a first bearing surface, the first portion of thetreatment device configured to engage a first portion of the airway withthe first bearing surface; and a second portion coupled to the firstportion of the treatment device, the second portion of the treatmentdevice having a structure with a centroid defining a second local axisand a second bearing surface, the second portion of the treatment deviceconfigured to engage a second portion of the airway with the secondbearing surface, the second portion of the airway being axially spacedapart from the first portion of the airway; wherein, in a deployedconfiguration within the lung, the first portion of the treatment devicepresses against the first portion of the airway to urge it to a morecoaxial orientation relative to the second local axis, and the secondportion of the treatment device presses against the second portion ofthe airway to urge it to a more coaxial orientation relative to thefirst local axis, thereby straightening the path through the airway incontact with the first and second portions of the treatment device.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within more than one airway of alung of a patient for treating the lung of the patient, the treatmentdevice comprising: a first portion having a first bearing surface anddefining a first local axis, the first portion of the treatment deviceconfigured to engage a first portion of a first airway with the firstbearing surface; and the treatment device further comprising a secondportion (can be a portion of a proximal v clip) coupled to the firstportion of the treatment device, a second portion of the treatmentdevice having a second bearing surface and defining a second local axis,the second portion of the treatment device configured to engage a secondportion of the first airway with the second bearing surface, the secondportion of the airway being axially spaced apart from the first portionof the first airway; a third portion coupled to the second portion ofthe treatment device having a third bearing surface and defining a thirdlocal axis, the third portion of the treatment device configured toengage a first portion of a second airway with the third bearingsurface; and a fourth portion (can be another tissue gathering end)coupled to the third portion of the treatment device, the fourth portionof the treatment device having a fourth bearing surface and defining afourth local axis, the fourth portion of the treatment device configuredto engage a second portion of the second airway with the fourth bearingsurface, the second portion of the second airway being axially spacedapart from the first portion of the second airway; wherein, in adeployed configuration within the lung, the first portion of thetreatment device presses against the first portion of the first airwayto urge it to a more coaxial orientation relative to the second localaxis in the first airway, and the second portion of the treatment devicepresses against the second portion of the first airway to urge it tomore a coaxial orientation relative to the first local axis, therebystraightening the path through the first airway in contact with thefirst and second portions of the treatment device and the third portionof the treatment device presses against the first portion of the secondairway to urge it to a more coaxial orientation relative to the fourthlocal axis in the second airway, and the fourth portion of the treatmentdevice presses against the second portion of the second airway to urgeit to more a coaxial orientation relative to the third local axis,thereby straightening the path through the second airway in contact withthe third and fourth portions of the treatment device.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within more than one airway of alung of a patient for treating the lung of the patient, the treatmentdevice comprising: a first portion having a first bearing surface havinga structure with a centroid defining a first local axis, the firstportion of the treatment device configured to engage a first portion ofa first airway with the first bearing surface; a second portion (can bea portion of a proximal v clip) coupled to the first portion of thetreatment device, the second portion of the treatment device having asecond bearing surface having a structure with a centroid defining asecond local axis, the second portion of the treatment device configuredto engage a second portion of the first airway with the second bearingsurface, the second portion of the first airway being axially spacedapart from the first portion of the first airway; a third portioncoupled to the second portion of the treatment device having a thirdbearing surface having a structure with a centroid defining a thirdlocal axis, the third portion of the treatment device configured toengage a first portion of a second airway with the third bearingsurface; and a fourth portion (can be another distal end) coupled to thethird portion of the treatment device, the fourth portion of thetreatment device having a fourth bearing surface having a structure witha centroid defining a fourth local axis, the fourth portion of thetreatment device configured to engage a second portion of the secondairway with the fourth bearing surface, the second portion of the secondairway being axially spaced apart from the first portion of the secondairway; wherein, in a deployed configuration within the lung, the firstportion of the treatment device presses against the first portion of thefirst airway to urge it to a more coaxial orientation relative to thesecond local axis in the first airway, and the second portion of thetreatment device presses against the second portion of the first airwayto urge it to more a coaxial orientation relative to the first localaxis, thereby straightening the path through the first airway in contactwith the first and second portions of the treatment device and the thirdportion of the treatment device presses against the first portion of thesecond airway to urge it to a more coaxial orientation relative to thefourth local axis in the second airway, and the fourth portion of thetreatment device presses against the second portion of the second airwayto urge it to more a coaxial orientation relative to the third localaxis, thereby straightening the path through the second airway incontact with the third and fourth portions of the treatment device.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within more than one airway of alung of a patient for treating the lung of the patient, the treatmentdevice comprising: a first portion having a first bearing surface havinga structure with a centroid defining a first local axis, the firstportion of the treatment device configured to engage a first portion ofa first airway with the first bearing surface; a second portion (can bea portion of a proximal v clip) coupled to the first portion of thetreatment device, the second portion of the treatment device having asecond bearing surface having a structure with a centroid defining asecond local axis, the second portion of the treatment device configuredto engage a second portion of the first airway with the second bearingsurface, the second portion of the first airway being axially spacedapart from the first portion of the first airway; a third portioncoupled to the second portion of the treatment device having a thirdbearing surface having a structure with a centroid defining a thirdlocal axis, the third portion of the treatment device configured toengage a first portion of a second airway with the third bearingsurface; and a fourth portion (can be another distal end) coupled to thethird portion of the treatment device, the fourth portion of thetreatment device having a fourth bearing surface having a structure witha centroid defining a fourth local axis, the fourth portion of thetreatment device configured to engage a second portion of the secondairway with the fourth bearing surface, the second portion of the secondairway being axially spaced apart from the first portion of the secondairway; wherein, in a deployed configuration within the lung, the firstportion of the treatment device presses against the first portion of thefirst airway to urge it to a more coaxial orientation relative to thesecond local axis in the first airway, and the second portion of thetreatment device presses against the second portion of the first airwayto urge it to more a coaxial orientation relative to the first localaxis, thereby straightening the path through the first airway in contactwith the first and second portions of the treatment device and the thirdportion of the treatment device presses against the first portion of thesecond airway to urge it to a more coaxial orientation relative to thefourth local axis in the second airway, and the fourth portion of thetreatment device presses against the second portion of the second airwayto urge it to more a coaxial orientation relative to the third localaxis, thereby straightening the path through the second airway incontact with the third and fourth portions of the treatment device;whereas the first and second portions of the treatment device are urgedcloser to the third and fourth portions of the treatment device in adeployed configuration within the lung.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within more than one airway of alung of a patient for treating the lung of the patient, the treatmentdevice comprising: a first portion having a first bearing surface havinga structure with a centroid defining a first local axis, the firstportion of the treatment device configured to engage a first portion ofa first airway with the first bearing surface; a second portion (can bea portion of a proximal v clip) coupled to the first portion of thetreatment device, the second portion of the treatment device having asecond bearing surface having a structure with a centroid defining asecond local axis, the second portion of the treatment device configuredto engage a second portion of the first airway with the second bearingsurface, the second portion of the first airway being axially spacedapart from the first portion of the first airway; a third portioncoupled to the second portion of the treatment device having a thirdbearing surface having a structure with a centroid defining a thirdlocal axis, the third portion of the treatment device configured toengage a first portion of a second airway with the third bearingsurface; and a fourth portion (can be another distal end) coupled to thethird portion of the treatment device, the fourth portion of thetreatment device having a fourth bearing surface having a structure witha centroid defining a fourth local axis, the fourth portion of thetreatment device configured to engage a second portion of the secondairway with the fourth bearing surface, the second portion of the secondairway being axially spaced apart from the first portion of the secondairway; wherein, in a deployed configuration within the lung, the firstportion of the treatment device presses against the first portion of thefirst airway to urge it to a more coaxial orientation relative to thesecond local axis in the first airway, and the second portion of thetreatment device presses against the second portion of the first airwayto urge it to more a coaxial orientation relative to the first localaxis, thereby straightening the path through the first airway in contactwith the first and second portions of the treatment device and the thirdportion of the treatment device presses against the first portion of thesecond airway to urge it to a more coaxial orientation relative to thefourth local axis in the second airway, and the fourth portion of thetreatment device presses against the second portion of the second airwayto urge it to more a coaxial orientation relative to the third localaxis, thereby straightening the path through the second airway incontact with the third and fourth portions of the treatment device;whereas the first and second portions of the treatment device are urgedcloser to the third and fourth portions of the treatment device in adeployed configuration within the lung; whereas the treatment deviceincreases tension in lung tissue in a deployed configuration within thelung.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within more than one airway of alung of a patient for treating the lung of the patient, the treatmentdevice comprising: a first portion having a first bearing surface havinga structure with a centroid defining a first local axis, the firstportion of the treatment device configured to engage a first portion ofa first airway with the first bearing surface; a second portion (can bea portion of a proximal v clip) coupled to the first portion of thetreatment device, the second portion of the treatment device having asecond bearing surface having a structure with a centroid defining asecond local axis, the second portion of the treatment device configuredto engage a second portion of the first airway with the second bearingsurface, the second portion of the first airway being axially spacedapart from the first portion of the first airway; a third portioncoupled to the second portion of the treatment device having a thirdbearing surface having a structure with a centroid defining a thirdlocal axis, the third portion of the treatment device configured toengage a first portion of a second airway with the third bearingsurface; and a fourth portion (can be another distal end) coupled to thethird portion of the treatment device, the fourth portion of thetreatment device having a fourth bearing surface having a structure witha centroid defining a fourth local axis, the fourth portion of thetreatment device configured to engage a second portion of the secondairway with the fourth bearing surface, the second portion of the secondairway being axially spaced apart from the first portion of the secondairway; wherein, in a deployed configuration within the lung, the firstportion of the treatment device presses against the first portion of thefirst airway to urge it to a more coaxial orientation relative to thesecond local axis in the first airway, and the second portion of thetreatment device presses against the second portion of the first airwayto urge it to more a coaxial orientation relative to the first localaxis, thereby straightening the path through the first airway in contactwith the first and second portions of the treatment device and the thirdportion of the treatment device presses against the first portion of thesecond airway to urge it to a more coaxial orientation relative to thefourth local axis in the second airway, and the fourth portion of thetreatment device presses against the second portion of the second airwayto urge it to more a coaxial orientation relative to the third localaxis, thereby straightening the path through the second airway incontact with the third and fourth portions of the treatment device;whereas the first and second portions of the treatment device are urgedcloser to the third and fourth portions of the treatment device in adeployed configuration within the lung; whereas the second and thirdportions of the treatment device are coupled by a resilient springmaterial.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within more than one airway of alung of a patient for treating the lung of the patient, the treatmentdevice comprising: a first portion having a first bearing surface havinga structure with a centroid defining a first local axis, the firstportion of the treatment device configured to engage a first portion ofa first airway with the first bearing surface; a second portion (can bea portion of a proximal v clip) coupled to the first portion of thetreatment device, the second portion of the treatment device having asecond bearing surface having a structure with a centroid defining asecond local axis, the second portion of the treatment device configuredto engage a second portion of the first airway with the second bearingsurface, the second portion of the first airway being axially spacedapart from the first portion of the first airway; a third portioncoupled to the second portion of the treatment device having a thirdbearing surface having a structure with a centroid defining a thirdlocal axis, the third portion of the treatment device configured toengage a first portion of a second airway with the third bearingsurface; and a fourth portion (can be another distal end) coupled to thethird portion of the treatment device, the fourth portion of thetreatment device having a fourth bearing surface having a structure witha centroid defining a fourth local axis, the fourth portion of thetreatment device configured to engage a second portion of the secondairway with the fourth bearing surface, the second portion of the secondairway being axially spaced apart from the first portion of the secondairway; wherein, in a deployed configuration within the lung, the firstportion of the treatment device presses against the first portion of thefirst airway to urge it to a more coaxial orientation relative to thesecond local axis in the first airway, and the second portion of thetreatment device presses against the second portion of the first airwayto urge it to more a coaxial orientation relative to the first localaxis, thereby straightening the path through the first airway in contactwith the first and second portions of the treatment device and the thirdportion of the treatment device presses against the first portion of thesecond airway to urge it to a more coaxial orientation relative to thefourth local axis in the second airway, and the fourth portion of thetreatment device presses against the second portion of the second airwayto urge it to more a coaxial orientation relative to the third localaxis, thereby straightening the path through the second airway incontact with the third and fourth portions of the treatment device;whereas the first and second portions of the treatment device are urgedcloser to the third and fourth portions of the treatment device in adeployed configuration within the lung; whereas the second and thirdportions of the treatment device are coupled by a resilient springmaterial; whereas at least one of the portions of the treatment deviceis covered with a jacket to increase the area that is engaged with aportion of an airway.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within more than one airway of alung of a patient for treating the lung of the patient, the treatmentdevice comprising: a first portion having a first bearing surface havinga structure with a centroid defining a first local axis, the firstportion of the treatment device configured to engage a first portion ofa first airway with the first bearing surface; a second portion (can bea portion of a proximal v clip) coupled to the first portion of thetreatment device, the second portion of the treatment device having asecond bearing surface having a structure with a centroid defining asecond local axis, the second portion of the treatment device configuredto engage a second portion of the first airway with the second bearingsurface, the second portion of the first airway being axially spacedapart from the first portion of the first airway; a third portioncoupled to the second portion of the treatment device having a thirdbearing surface having a structure with a centroid defining a thirdlocal axis, the third portion of the treatment device configured toengage a first portion of a second airway with the third bearingsurface; and a fourth portion (can be another distal end) coupled to thethird portion of the treatment device, the fourth portion of thetreatment device having a fourth bearing surface having a structure witha centroid defining a fourth local axis, the fourth portion of thetreatment device configured to engage a second portion of the secondairway with the fourth bearing surface, the second portion of the secondairway being axially spaced apart from the first portion of the secondairway; wherein, in a deployed configuration within the lung, the firstportion of the treatment device presses against the first portion of thefirst airway to urge it to a more coaxial orientation relative to thesecond local axis in the first airway, and the second portion of thetreatment device presses against the second portion of the first airwayto urge it to more a coaxial orientation relative to the first localaxis, thereby straightening the path through the first airway in contactwith the first and second portions of the treatment device and the thirdportion of the treatment device presses against the first portion of thesecond airway to urge it to a more coaxial orientation relative to thefourth local axis in the second airway, and the fourth portion of thetreatment device presses against the second portion of the second airwayto urge it to more a coaxial orientation relative to the third localaxis, thereby straightening the path through the second airway incontact with the third and fourth portions of the treatment device;whereas the first and second portions of the treatment device are urgedcloser to the third and fourth portions of the treatment device in adeployed configuration within the lung; whereas the second and thirdportions of the treatment device are coupled by a resilient springmaterial; whereas at least one of the portions of the treatment deviceis covered with a jacket to increase the area that is engaged with aportion of an airway; whereas the first and fourth portions of thetreatment device are covered with a jacket to increase the area that isengaging the first portion of the first airway and second portion of thesecond airway.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within more than one airway of alung of a patient for treating the lung of the patient, the treatmentdevice comprising: a first portion having a first bearing surface havinga structure with a centroid defining a first local axis, the firstportion of the treatment device configured to engage a first portion ofa first airway with the first bearing surface; a second portion (can bea portion of a proximal v clip) coupled to the first portion of thetreatment device, the second portion of the treatment device having asecond bearing surface having a structure with a centroid defining asecond local axis, the second portion of the treatment device configuredto engage a second portion of the first airway with the second bearingsurface, the second portion of the first airway being axially spacedapart from the first portion of the first airway; a third portioncoupled to the second portion of the treatment device having a thirdbearing surface having a structure with a centroid defining a thirdlocal axis, the third portion of the treatment device configured toengage a first portion of a second airway with the third bearingsurface; and a fourth portion (can be another distal end) coupled to thethird portion of the treatment device, the fourth portion of thetreatment device having a fourth bearing surface having a structure witha centroid defining a fourth local axis, the fourth portion of thetreatment device configured to engage a second portion of the secondairway with the fourth bearing surface, the second portion of the secondairway being axially spaced apart from the first portion of the secondairway; wherein, in a deployed configuration within the lung, the firstportion of the treatment device presses against the first portion of thefirst airway to urge it to a more coaxial orientation relative to thesecond local axis in the first airway, and the second portion of thetreatment device presses against the second portion of the first airwayto urge it to more a coaxial orientation relative to the first localaxis, thereby straightening the path through the first airway in contactwith the first and second portions of the treatment device and the thirdportion of the treatment device presses against the first portion of thesecond airway to urge it to a more coaxial orientation relative to thefourth local axis in the second airway, and the fourth portion of thetreatment device presses against the second portion of the second airwayto urge it to more a coaxial orientation relative to the third localaxis, thereby straightening the path through the second airway incontact with the third and fourth portions of the treatment device;whereas the first and second portions of the treatment device are urgedcloser to the third and fourth portions of the treatment device in adeployed configuration within the lung; whereas the second and thirdportions of the treatment device are coupled by a resilient springmaterial; whereas at least one of the portions of the treatment deviceis covered with a jacket, selected from the materials defined as jacketmaterials in this specification, to increase the area that is engagedwith a portion of an airway; whereas the first and fourth portions ofthe treatment device are covered with a jacket to increase the area thatis engaging the first portion of the first airway and second portion ofthe second airway.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a jacket to increase the area that isengaged with lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a jacket, made from material listed in thisspecification defined as jacket materials, to increase the area that isengaged with lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a jacket to increase the area that isengaged with lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a jacket, made from a polymer, to increasethe area that is engaged with lung tissue.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a jacket, made from a polymer material,that regulates the rate of release of a therapeutic drug.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured with a jacket, made from a polymer material,that regulates the rate of release of a therapeutic drug; whereas thetherapeutic drug reduces the rate of wound healing, tissue remodeling,inflammation, generation of granular tissue or a combination of these.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within an airway of a lung of apatient for treating the lung of the patient, the treatment devicecomprising: an elongate body having a proximal end and a distal end; theelongate body configured to transition between a delivery configurationand a deployed configuration; and wherein the deployed configuration ofthe elongate body exerts force on the airway to straighten a portion ofthe airway that is axially spaced between the proximal and distal end ofthe treatment device for reducing air flow resistance in the lung; andwherein the elongate body is configured to increases tension in lungtissue to bring benefits related to increasing lung tension.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within an airway of a lung of apatient for treating the lung of the patient, the treatment devicecomprising: an elongate body having a proximal end and a distal end; theelongate body configured to transition between a delivery configurationand a deployed configuration; and wherein the deployed configuration ofthe elongate body exerts force on the airway to straighten a portion ofthe airway that is axially spaced between the proximal and distal end ofthe treatment device for reducing air flow resistance in the lung; andwherein the elongate body is configured to increases tension in lungtissue to bring benefits related to increasing lung tension; and whereinthe elongate body is configured to elute a therapeutic drug.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within an airway of a lung of apatient for treating the lung of the patient, the treatment devicecomprising: an elongate body having a proximal end and a distal end; theelongate body configured to transition between a delivery configurationand a deployed configuration; and wherein the deployed configuration ofthe elongate body exerts force on the airway to straighten a portion ofthe airway that is axially spaced between the proximal and distal end ofthe treatment device for reducing air flow resistance in the lung; andwherein the elongate body is configured to increases tension in lungtissue to bring benefits related to increasing lung tension; and whereinthe elongate body is configured to elute a therapeutic drug; wherein thetherapeutic drug is configured to locally reduce a wound healing rate.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within an airway of a lung of apatient for treating the lung of the patient, the treatment devicecomprising: an elongate body having a proximal end and a distal end; theelongate body configured to transition between a delivery configurationand a deployed configuration; and wherein the deployed configuration ofthe elongate body exerts force on the airway to straighten a portion ofthe airway that is axially spaced between the proximal and distal end ofthe treatment device for reducing air flow resistance in the lung; andwherein the elongate body is configured to increases tension in lungtissue to bring benefits related to increasing lung tension; and whereinthe elongate body is configured to elute a therapeutic drug; wherein thetherapeutic drug is configured to locally reduce tissue remodeling.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within an airway of a lung of apatient for treating the lung of the patient, the treatment devicecomprising: an elongate body having a proximal end and a distal end; theelongate body configured to transition between a delivery configurationand a deployed configuration; and wherein the deployed configuration ofthe elongate body exerts force on the airway to straighten a portion ofthe airway that is axially spaced between the proximal and distal end ofthe treatment device for reducing air flow resistance in the lung; andwherein the elongate body is configured to increases tension in lungtissue to bring benefits related to increasing lung tension; and whereinthe elongate body is configured to elute a therapeutic drug; wherein thetherapeutic drug is configured to locally reduce inflammation.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within an airway of a lung of apatient for treating the lung of the patient, the treatment devicecomprising: an elongate body having a proximal end and a distal end; theelongate body configured to transition between a delivery configurationand a deployed configuration; and wherein the deployed configuration ofthe elongate body exerts force on the airway to straighten a portion ofthe airway that is axially spaced between the proximal and distal end ofthe treatment device for reducing air flow resistance in the lung; andwherein the elongate body is configured to increases tension in lungtissue to bring benefits related to increasing lung tension; and whereinthe elongate body is configured to elute a therapeutic drug; wherein thetherapeutic drug is configured to reduce granular tissue formation.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within an airway of a lung of apatient for treating the lung of the patient, the treatment devicecomprising: an elongate body having a proximal end and a distal end; theelongate body configured to transition between a delivery configurationand a deployed configuration; and wherein the deployed configuration ofthe elongate body exerts force on the airway to straighten a portion ofthe airway that is axially spaced between the proximal and distal end ofthe treatment device for reducing air flow resistance in the lung; andwherein the elongate body is configured to increases tension in lungtissue to bring benefits related to increasing lung tension; and whereinthe elongate body is configured to elute a therapeutic drug; wherein thetherapeutic drug is configured to reduce hyperplasia.

In another aspect of the present invention, a pulmonary treatment deviceis provided, configured to be deployed within an airway of a lung of apatient for treating the lung of the patient, the treatment devicecomprising: an elongate body having a proximal end and a distal end; theelongate body configured to transition between a delivery configurationand a deployed configuration; and wherein the deployed configuration ofthe elongate body exerts force on the airway to straighten a portion ofthe airway that is axially spaced between the proximal and distal end ofthe treatment device for reducing air flow resistance in the lung; andwherein the elongate body is configured to increases tension in lungtissue to bring benefits related to increasing lung tension; and whereinthe elongate body is configured to elute a therapeutic drug; wherein theelongate body comprises a polymer material and wherein the polymermaterial regulates a release of the therapeutic drug.

In another aspect of the present invention, a method is provided fortreating a lung comprising: deploying an implantable pulmonary treatmentdevice to the airway of the lung, the treatment device comprising anelongate body having a proximal end and a distal end that can berepositioned; wherein the distal end of the elongate body is deployed toanchor to lung tissue, the proximal end of the elongate body is deployedto an initial position to anchor to lung tissue in a repositionable way,the proximal end is repositioned to a position farther from the distalend of the treatment device than the proximal end initial deployedposition so that the elongate body and airway are urged to a morestraight configuration.

In another aspect of the present invention, a method is provided fortreating a lung comprising: deploying an implantable pulmonary treatmentdevice to the airway of the lung, the treatment device comprising anelongate body having a proximal end and a distal end that can berepositioned; wherein the distal end of the elongate body is deployed toanchor to lung tissue, the proximal end of the elongate body is deployedto an initial position to anchor to lung tissue in a repositionable way,the proximal end is repositioned to a position farther from the distalend of the treatment device than the proximal end initial deployedposition so that the elongate body and airway are urged to a morestraight configuration; wherein the elongate body of the treatmentdevice is configured to tension lung tissue to bring benefits related toincreasing lung tension.

In another aspect of the present invention, a method is provided fortreating a lung comprising: deploying an implantable pulmonary treatmentdevice to the airway of the lung, the treatment device comprising anelongate body having a proximal end and a distal end that can berepositioned; wherein the distal end of the elongate body is deployed toanchor to lung tissue, the proximal end of the elongate body is deployedto an initial position to anchor to lung tissue in a repositionable way,the proximal end is repositioned to a position farther from the distalend of the treatment device than the proximal end initial deployedposition so that the elongate body and airway are urged to a morestraight configuration; wherein the elongate body of the treatmentdevice is configured to increase tension of lung tissue that lie alongdirectional vectors between the treatment device and chest wall.

In another aspect of the present invention, a method is provided fortreating a lung comprising: deploying a pulmonary treatment device tothe airway of the lung, the treatment device comprising an elongate bodyhaving a proximal end and a distal end that can be repositioned; whereinthe distal end of the elongate body is deployed to anchor to lungtissue, the proximal end of the elongate body is deployed to an initialposition to anchor to lung tissue in a repositionable way, the proximalend is repositioned to a position farther from the distal end of thetreatment device than the proximal end initial deployed position so thatthe elongate body and airway are urged to a more straight configuration;wherein the elongate body of the treatment device is configured toincrease tension of lung tissue that lies between the treatment deviceand the chest wall.

In another aspect of the present invention, a method is provided fortreating a lung comprising: deploying a pulmonary treatment device tothe airway of the lung, the treatment device comprising an elongate bodyhaving a proximal end and a distal end that can be repositioned; whereinthe distal end of the elongate body is deployed to anchor to lungtissue, the proximal end of the elongate body is deployed to an initialposition to anchor to lung tissue in a repositionable way, the proximalend is repositioned to a position farther from the distal end of thetreatment device than the proximal end initial deployed position so thatthe elongate body and airway are urged to a more straight configuration;wherein the elongate body of the treatment device is configured to elutea therapeutic drug.

In another aspect of the present invention, a method is provided fortreating a lung comprising: deploying a tissue engaging end of apulmonary treatment device into loose damaged alveolar sac tissue distalto a lung passageway; pulling the tissue engaging end toward the lungpassageway so that a portion of the lung associated with the loosedamaged alveolar sac tissue is re-tensioned; and seating a stabilizingend of the pulmonary treatment device into the lung passageway so as tomaintain re-tensioning of the portion of the lung.

In another aspect of the present invention, a method is provided totreat a lung comprising: providing a pulmonary treatment device with aproximal end configured to be a stabilizing end, a distal end configuredto be a tissue gathering end and an elastic midsection that is connectedto the stabilizing end and the tissue gathering ends and a deliverydevice configured to seat the stabilizing end of the pulmonary treatmentdevice into the lung passageway; apply force to stress the elasticmidsection of the treatment device so it is strained to a longer lengthand the distal tissue gathering end of the lung treatment device isadvanced further within the lung; fix the tissue engaging end of thetreatment device to the lung and then remove the delivery device toallow the elastic midsection to stent the lumen of the lung passagewaywhile applying compressive stress on the lung tissue near the treatmentdevice and to tension portions of the lung that are adjacent to thetreatment device.

In another aspect of the present invention, a method is provided forreducing the distance between two locations in a lung to increasetension in locations in the lung that are not between the two locations.The method includes the steps of providing a device with at least twoanchors and an elastic midsection that can be elongated to store elasticrecoil strain energy, anchoring at a first location in the lung a firstanchor, elongating the midsection to store elastic recoil strain energy,anchoring at a second location a second anchor where the second locationis distant from the first location, allow the midsection with storedelastic recoil strain energy to reduce the distance between the anchoredfirst location and the anchored second location to decrease the distancebetween the two locations to increase tension in locations in the lungthat are not between the two anchored locations.

In another aspect of the present invention, a method is provided forreducing the distance between two locations in a lung to increasetension in locations in the lung that are not between the two locations.The method includes the steps of providing a device with at least twoanchors and an elastic midsection that can store elastic recoil strainenergy, anchoring at a first location in the lung a first anchor,anchoring at a second location a second anchor where the second locationis distant from the first location, reducing the distance between theanchored first location and the anchored second location to decrease thedistance between the two locations to increase tension in locations inthe lung that are not between the two anchored locations.

In another aspect of the present invention, a method is provided forreducing the distance between two locations in a lung to increasetension in locations in the lung that are not between the two locations.The method includes the steps of providing a device with at least twoanchors and an elastic midsection that can store elastic recoil strainenergy, anchoring at a first location in the lung a first anchor,anchoring at a second location a second anchor where the second locationis distant from the first location, reducing the distance between theanchored first location and the anchored second location to decrease thedistance between the two locations to increase tension in locations inthe lung that are not between the two anchored locations using storedelastic recoil strain energy.

In another aspect of the present invention, a method is provided fortreating a lung comprising: advancing a lung treatment device comprisinga tissue gathering distal end, a stabilizing proximal end, bothconnected to an elastic midsection; a delivery device comprising abronchoscope, a deployment sleeve and a guidewire into a lung airway;advancing the treatment device through a lung airway until thestabilizing end or proximal end of the treatment device seats in thelung airway whereby the user continues to advance the non-stabilizingproximal end portion of the treatment device until the mid-section isextended or lengthened; deploying a tissue anchoring feature of thedistal end of the pulmonary treatment device to allow the elasticmidsection of the treatment device to pull lung tissue towards thecenter of the elastic midsection to increase tension in adjacent lungtissue. After removing the delivery system, the lung elastic recoiltension would be enhanced in the lung. By performing this method oftreatment, one end of the treatment device is fixed to lung tissue, thetreatment device is lengthened to store strain energy to fullyelastically lengthen the device and the distal portion is then fixed tolung tissue. After removing the bronchoscope and related delivery systemcomponents such as a guidewire and deployment sleeve, the lung treatmentdevice utilizes the stored strain energy to recover back to an originalunstressed length and this pulls the tissue engaging end toward the lungpassageway so that a portion of the lung associated with the distal orloose damaged alveolar sac tissue is re-tensioned and the seatedstabilizing end of the pulmonary treatment device is pulled into thelung tissue so as to maintain re-tensioning of a large portion of thelung. The elastic midsection of the treatment device may be configuredto stent the lung airway while enhancing lung tension as the airwaytissue that is in contact with the elastic mid-section may be compressedover time and prone to allow lumen collapse during breathing. Theelastic midsection of the treatment device may be made from a laser cuttube or a coiled or braided wire.

In another aspect of the invention, a method is provided to advance anddeploy a pulmonary treatment device using a guidewire a deploymentsleeve and a bronchoscope guide sleeve to 1) seat the proximal anchor ofthe treatment device which has been described as the stabilizing end ofthe treatment device, 2) advance the distal anchor structure that hasbeen defined in as the tissue gathering end portion of the treatmentdevice so that the midsection of the treatment device is elongated in afully reversibly elastic way, 3) the deployment sleeve appliescompressive force against the tissue gathering end portion of thetreatment device to maintain the extended length of the mid-sectionwhile the bronchoscope is removed, 4) withdrawing the bronchoscopeactivates the anchor feature that is attached to the tissue gatheringend so the distal portion of the treatment device is fixed to the lungtissue while 5) the guidewire, deployment sleeve and bronchoscope arefully removed from the lung to 6) allow the elastic recoil properties ofthe pulmonary treatment device to re-tension the area of loose damagedalveolar sac tissue, 7) pull the distal and proximal ends of thetreatment device closer together 8) reduce compliance of the lung and 9)maintain the re-tension of the area of loose damaged alveolar sac tissueto enhance radial outward force to airways so symptoms of COPD arereduced or eliminated.

In another aspect of the present invention, a method is provided fortreating a lung comprising the steps of: advancing a lung treatmentsystem to a treatment location comprising a delivery system element witha distal end, a proximal end and a lung treatment device configured toat least partially encircle the delivery system element while the systemis used to treat a patient, elongating the treatment device anddeploying the device into the lung to tension lung tissue.

In another aspect of the present invention, a method is provided fortreating a lung comprising the steps of: advancing a lung treatmentsystem to a treatment location comprising a delivery system element witha distal end, a proximal end and a length which is longer than 2 timesthe largest transverse dimension of the element, a pulmonary treatmentdevice configured to at least partially encircle the delivery systemelement while the system is advanced into a patient and elongating thetreatment device and deploying the device into the lung to enhance lungelastic recoil.

In another aspect of the present invention, a method is provided fortreating a lung comprising the steps of: advancing a lung treatmentsystem comprising a delivery system element with a distal end, aproximal end and a length which is longer than 2 times the largesttransverse dimension of the element, a pulmonary treatment deviceconfigured to at least partially encircle the delivery system elementwhile the system is advanced into a patient to deliver the treatmentdevice to a treatment location in the lung, elongating the treatmentdevice and deploying the device into the lung to pull lung tissuetowards the treatment device centroid.

In another aspect of the present invention, a method is provided fortreating a lung comprising the steps of: advancing a lung treatmentsystem comprising a delivery system element with a distal end, aproximal end and a length which is longer than 2 times the largesttransverse dimension of the element and an implantable pulmonarytreatment device configured to at least partially encircle the deliverysystem element while the system is advanced into a patient to deliverthe treatment device to a treatment location in the lung, elongating thetreatment device and deploying the treatment device in the lung tobeneficially stress tissue in the lung.

In another aspect of the present invention, a method is provided fortreating a lung comprising the steps of: advancing a lung treatmentsystem comprising a delivery system canula with a distal end, a proximalend and a length which is longer than 2 times the largest transversedimension of the canula, a pulmonary treatment device configured to atleast partially encircle the delivery system canula while the system isadvanced into a patient to deliver the treatment device to a treatmentlocation in the lung and implant the treatment device in the lung toenhance lung elastic recoil and reduce symptoms of COPD.

In another aspect of the present invention, a method is provided fortreating a lung comprising the steps of: advancing a lung treatmentsystem comprising a delivery system canula with a distal end, a proximalend and a length which is longer than 2 times the largest transversedimension of the canula, a pulmonary treatment device configured to atleast partially encircle the delivery system canula while the system isadvanced into a patient to deliver the treatment device to a treatmentlocation in the lung, elongate the treatment device and deploy thetreatment device in the lung to tension lung tissue.

In another aspect of the present invention, a method is provided fortreating a lung comprising the steps of: advancing a lung treatmentsystem comprising a bronchoscope with a distal end, a proximal end and alength which is longer than 2 times the largest transverse dimension ofworking length portion of the bronchoscope, a pulmonary treatment deviceconfigured to at least partially encircle the bronchoscope while thesystem is advanced into a patient to deliver the treatment device to atreatment location in the lung, elongate the treatment device andimplanted it in the lung to treat COPD.

In another aspect of the present invention, a lung treatment method isprovided for treating a lung comprising the steps of; providing abronchoscope with a distal end, a proximal end and a length which islonger than 5 inches and a pulmonary treatment device with a distaltissue gathering end, a proximal tissue stabilizing end and amidsection. The treatment device is configured to at least partiallyencircle the bronchoscope while the system is advanced into a patient todeliver the treatment device to a lung. The method includes anchoringthe tissue gathering end at a first location, anchoring the tissuestabilizing end at a second location which is distant from the firstlocation and reducing the distance between the first and secondlocations to increase tension in a portion of the lung that is notbetween the first and second locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing a bronchoscope with a distalend, a proximal end and a length which is longer than 5 inches, apulmonary treatment device with a distal tissue gathering end, aproximal tissue stabilizing end and a midsection which is configured tobe able to store elastic strain energy. Additionally, the treatmentdevice is configured to at least partially encircle the bronchoscopewhile the system is advanced into a patient to deliver the treatmentdevice to a lung. The method includes anchoring the tissue gathering endat a first location, anchoring the tissue stabilizing end at a secondlocation which is distant from the first location and allowing storedelastic strain energy to reduce the distance between the first andsecond locations to increase tension in a portion of the lung that isnot between the first and second locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing a bronchoscope with a distalend, a proximal end and a length which is longer than 5 inches, a lungtreatment device with a distal tissue gathering end, a proximal tissuestabilizing end and a midsection which is configured to be able to storeelastic strain energy. The method includes anchoring the tissuegathering end at a first location, anchoring the tissue stabilizing endat a second location which is distant from the first location andallowing stored elastic strain energy to reduce the distance between thefirst and second locations to increase tension in a portion of the lungthat is not between the first and second locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing an elongate delivery systemshaft with a distal end, a proximal end and a length which is longerthan 5 inches, a lung treatment device with a distal tissue gatheringend, a proximal tissue stabilizing end and a midsection which isconfigured to be able to store elastic strain energy. The methodincludes anchoring the tissue gathering end at a first location,anchoring the tissue stabilizing end at a second location which isdistant from the first location and allowing stored elastic strainenergy to reduce the distance between the first and second locations toincrease tension in a portion of the lung that is not between the firstand second locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing an elongate delivery systemshaft with a distal end, a proximal end and a length which is longerthan 5 inches, a pulmonary treatment device with a distal tissuegathering end, a proximal tissue stabilizing end and a midsection whichis configured to be able to store elastic strain energy. Additionally,the pulmonary treatment device is configured to at least partiallyencircle the elongate delivery system shaft. The method includesanchoring the tissue gathering end at a first location, anchoring thetissue stabilizing end at a second location which is distant from thefirst location and allowing stored elastic strain energy to reduce thedistance between the first and second locations to increase tension in aportion of the lung that is not between the first and second locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing an elongate delivery systemshaft with a distal end, a proximal end and a length which is longerthan 5 inches, a pulmonary treatment device with a distal tissuegathering end, a proximal tissue stabilizing end and a midsection whichis configured to be able to store elastic strain energy. Additionally,the treatment device is configured to at least partially encircle theelongate delivery system shaft. The method includes anchoring the tissuegathering end at a first location, anchoring the tissue stabilizing endat a second location which is distant from the first location andreducing the distance between the first and second locations to increasetension in a portion of the lung that is not between the first andsecond locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing an elongate delivery systemshaft with a distal end, a proximal end and a length which is longerthan 5 inches, a pulmonary treatment device with a distal tissuegathering end, a proximal tissue stabilizing end and a midsection whichis configured to be able to store elastic strain energy. The methodincludes anchoring the tissue gathering end at a first location,anchoring the tissue stabilizing end at a second location which isdistant from the first location and reducing the distance between thefirst and second locations to increase tension in a portion of the lungthat is not between the first and second locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing a pulmonary treatmentdevice, a bronchoscope and a bronchoscope guide sleeve whereas thetreatment device is configured with a proximal end, a distal end and amidsection that incorporates a lumen running through the treatmentdevice proximal end and midsection along the central axis between thedistal end and the proximal ends, a bronchoscope guide sleeve isconfigured with a proximal end, a distal end and a lumen running throughthe full length of the bronchoscope guide sleeve along the central axisbetween the distal end and proximal end; a bronchoscope that isconfigured to be advanced through the bronchoscope guide sleeve andthrough the proximal end and midsection of the treatment device in a waythat allows the lung treatment device length to be lengthened orshortened by sliding the bronchoscope guide sleeve, which has beenattached to the lung treatment device, along the axis of the coaxialbronchoscope. Further, the treatment device distal end is anchored to afirst location in the lung, the treatment device proximal end isanchored to a second location in the lung which is distant from thefirst location and the treatment device is shortened to reduce thedistance between the two locations in the lung to increase tension inareas in the lung that are not between the two locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing a pulmonary treatmentdevice, a bronchoscope and a bronchoscope guide sleeve whereas the lungtreatment device is configured with a proximal end, a distal end and amidsection. The treatment device can be elongated to store elasticstrain energy. The treatment device may also be attached to thebronchoscope and the bronchoscope guide sleeve. The bronchoscope guidesleeve is configured with a proximal end, a distal end and a lumenrunning therethrough along its longitudinal axis. The bronchoscope isconfigured to be advanced through the bronchoscope guide sleeve andthrough the treatment device in a way that allows the lung treatmentdevice length to be lengthened or shortened by sliding the bronchoscopeguide sleeve along the axis of the coaxial bronchoscope. Further, thetreatment device distal end is anchored to a first location in the lung,the treatment device proximal end is anchored to a second location inthe lung which is distant from the first location and the treatmentdevice is shortened to reduce the distance between the two locations inthe lung to increase tension in areas in the lung that are not betweenthe first or second anchored locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing a pulmonary treatmentdevice, a bronchoscope and a bronchoscope guide sleeve whereas thetreatment device is configured with a proximal end, a distal end and amidsection. The treatment device can be elongated to store elasticstrain energy. The treatment device may also be attached to thebronchoscope and the bronchoscope guide sleeve. The bronchoscope guidesleeve is configured with a proximal end, a distal end and a lumenrunning therethrough along its longitudinal axis. The bronchoscope isconfigured to be advanced through the bronchoscope guide sleeve andthrough the treatment device in a way that allows the treatment devicelength to be lengthened or shortened by sliding the bronchoscope guidesleeve along the axis of the coaxial bronchoscope. Further, thetreatment device is elongated to store elastic strain energy, distal endis anchored to a first location in the lung, the treatment deviceproximal end is anchored to a second location in the lung which isdistant from the first location and the treatment device is shortened toreduce the distance between the two locations in the lung to increasetension in areas in the lung that are not between the first or secondanchored locations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of providing a pulmonary treatmentdevice, a bronchoscope and a bronchoscope guide sleeve whereas thetreatment device is configured with a proximal end, a distal end and amidsection. The treatment device can be elongated to store elasticstrain energy. The treatment device may also be attached to thebronchoscope and the bronchoscope guide sleeve. The bronchoscope guidesleeve is configured with a proximal end, a distal end and a lumenrunning therethrough along its longitudinal axis. The bronchoscope isconfigured to be advanced through the bronchoscope guide sleeve andthrough the lung treatment device in a way that allows the lungtreatment device length to be lengthened or shortened by sliding thebronchoscope guide sleeve along the axis of the coaxial bronchoscope.Further, the treatment device is elongated to store elastic strainenergy, distal end is anchored to a first location in the lung, the lungtreatment device proximal end is anchored to a second location in thelung which is distant from the first location and the stored elasticstrain energy is allowed to shorten the lung treatment device to reducethe distance between the two locations in the lung to increase tensionin areas in the lung that are not between the first or second anchoredlocations.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying the tissue gathering end ofa pulmonary treatment device in an airway at a location more distal froma bifurcation than the length of the pulmonary treatment device, pullingthe undeployed portion of the device proximally and then deploying thestabilizing end at the bifurcation.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying the tissue gathering end ofa pulmonary treatment device in an airway at a location more distal froma stabilizing end target location than the length of the device, pullingthe undeployed portion of the device proximally and then deploying thestabilizing end at the proximal stabilizing end target location.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying the tissue gathering end ofa pulmonary treatment device in an airway at a location more distal froma bifurcation than the length of the device, deploying the rest of thedevice and then tensioning the stabilizing end of the device to placethe stabilizing end at the airway ostium or bifurcation.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying the tissue gathering end ofa pulmonary treatment device in an airway at a location more distal froma stabilizing end target location than the length of the device,deploying the rest of the device and then tensioning the stabilizing endof the device to place the stabilizing end at the stabilizing end targetlocation.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying the tissue gathering end ofa pulmonary treatment device in an airway at a location more distal froma bifurcation than the length of the pulmonary treatment device,deploying the rest of the pulmonary treatment device and then tensioninga portion of the pulmonary treatment device to allow the stabilizing endto be placed at the airway ostium or bifurcation.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying the tissue gathering end ofa pulmonary treatment device in an airway at a location more distal froma stabilizing end target location than the length of the pulmonarytreatment device, deploying the rest of the pulmonary treatment deviceand then tensioning a portion of the pulmonary treatment device to allowthe stabilizing end to be placed at the stabilizing end target location.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of installing a shape-memory alloymedical device within a human lung so that the device is substantiallyat body temperature wherein the shape-memory alloy medical devicedisplays reversible stress-induced or strain induced martensite at bodytemperature to straighten a lung airway, the method further comprising:deforming the medical device into a deformed shape different from afinal shape; restraining the deformed shape of the medical device by theapplication of a restraining mechanism; positioning the medical deviceand restraining mechanism within the lung; and removing the restrainingmechanism to allow the device to recover from the deformed shape intothe final shape.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of installing a shape-memory alloymedical device within a human lung so that the device is substantiallyat body temperature wherein the shape-memory alloy medical devicedisplays reversible stress-induced or strain induced martensite at bodytemperature to straighten a lung airway, the method further comprising:deforming the medical device into a deformed shape different from afinal shape; restraining the deformed shape of the medical device by theapplication of a restraining mechanism; positioning the medical deviceand restraining mechanism within the lung; and removing the restrainingmechanism to allow the device to recover from the deformed shape intothe final shape; whereby the device tensions lung tissue.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of tensioning lung tissue by: deliveringto the lung a resilient medical device with a distal end, a proximal endand a connected midsection; anchoring at least a portion of the distalend at a first position in the lung; displacing at least a portion ofthe proximal end to a position that is distant from the anchored atleast portion of the distal end; anchoring at least a portion of theproximal end at a second position in the lung.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of tensioning lung tissue by: deliveringto the lung a resilient medical device with a distal end, a proximal endand a connected midsection; anchoring at least a portion of the distalend at a first position in the lung; displacing at least a portion ofthe proximal end to a position that is distant from the anchored atleast portion of the distal end; anchoring at least a portion of theproximal end at a second position in the lung, whereas displacing theproximal end lengthens the device.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of tensioning lung tissue by: deliveringto the lung a resilient medical device with a distal end, a proximal endand a connected midsection; anchoring a at least portion of the distalend at a first position in the lung; displacing a at least portion ofthe proximal end to a position that is distant from the anchored atleast portion of the distal end to tension the device; anchoring atleast a portion of the proximal end at a second position in the lung.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of straightening a lung airway by:delivering to the lung a resilient medical device with a distal end, aproximal end and a connected midsection; anchoring at least a portion ofthe distal end at a first position in the lung; displacing at least aportion of the proximal end to a position that is distant from theanchored at least portion of the distal end in a way that straightensthe lung airway; anchoring at least a portion of the proximal end at asecond position in the lung.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of tensioning a lung airway by:delivering to the lung a resilient medical device a with distal end, aproximal end and a connected midsection; anchoring at least a portion ofthe distal end at a first position in a lung airway; displacing at leasta portion of the proximal end to a position that is distant from theanchored at least portion of the distal end in a way that tensions thelung airway; anchoring at least at least a portion of the proximal endat a second position in another lung airway.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of tensioning a lung airway by:delivering to the lung a resilient medical device with a distal end, aproximal end and a connected midsection; anchoring at least a portion ofthe distal end at a first position in a lung airway; displacing at leasta portion of the proximal end to a position that is distant from theanchored at least portion of the distal end in a way that tensions thelung airway; anchoring at least at least a portion of the proximal endat a second position in another at least portion of the same lungairway.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of tensioning lung tissue without causinglung volume reduction, the steps include: delivering to the lung aresilient medical device a with distal end, a proximal end and aconnected midsection; anchoring at least a portion of the distal end ata first position in a lung; displacing at least a portion of theproximal end to a position in the lung that is distant from the anchoredat least portion of the distal end to cause the midsection of the deviceto be elongated; anchoring at least a portion of the proximal end at thedistant position in the lung, whereas all adjacent lung tissue has beentensioned and no lung tissue has been compressed to cause lung volumereduction.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of tensioning lung tissue without causinglung volume reduction, the steps include: delivering to the lung aresilient medical device with a distal end, a proximal end and aconnected midsection; anchoring at least a portion of the proximal endat a first position in the lung; displacing a portion of the distal endto a position in the lung that is distant from the anchored at leastportion of the proximal end to cause the midsection of the device to beelongated; anchoring at least a portion of the distal end at the distantposition in the lung, whereas all adjacent lung tissue has beentensioned and no lung tissue has been compressed to cause lung volumereduction.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying a resilient airwaystraightening medical device comprising an elongate body and at leastone end that can be attached to lung tissue; attaching the end to atleast a portion of a lung and; pulling the device to cause the attachedend to pull on lung tissue to straighten a portion of a lung airway.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying a resilient airwaystraightening medical device comprising an elongate body and at leastone end that can be attached to lung tissue; attaching the end to atleast a portion of a lung and; pulling the device to cause the attachedend to pull on lung tissue to straighten a portion of a lung airway in away that causes no lung volume reduction or tissue compression to occur.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying a resilient airwaystraightening medical device comprising an elongate body and at leastone end configured to be attached to lung tissue; attaching the end toat least a portion of a lung; and pulling the device to cause theattached end to pull on lung tissue to straighten a portion of a lungairway.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying a pulmonary treatment devicefrom a delivery device within a lung airway; the pulmonary treatmentdevice comprising a tissue gathering end, a stabilizing end, and aresilient tether extending between the tissue gathering end andstabilizing end; the device configured such that the distance betweenthe ends is increased then the ends are attached to lung tissue beforereleasing the pulmonary treatment device from a delivery device.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying a pulmonary treatment devicefrom a delivery device within a lung airway; the pulmonary treatmentdevice comprising a tissue gathering end, a stabilizing end, and aresilient tether extending between the tissue gathering end andstabilizing end, the device configured such that the distance betweenthe ends is increased and the ends are attached to a lung airway beforereleasing the pulmonary treatment device from a delivery device; thusstraightening the lung airway.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying a pulmonary treatment devicefrom a delivery device within a lung airway; the pulmonary treatmentdevice comprising a tissue gathering end, a stabilizing end, and aresilient tether extending between the tissue gathering end andstabilizing end, the device configured such that the distance betweenthe ends is increased; the ends are attached to lung tissue; thepulmonary treatment device is released from the delivery device toincrease tension between the ends.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of deploying a pulmonary treatment devicefrom a delivery device within a lung airway; the pulmonary treatmentdevice comprising a tissue gathering end, a stabilizing end, and aresilient tether extending between the tissue gathering end andstabilizing end, the device configured such that the distance betweenthe ends is increased; and the ends are attached to lung tissue beforereleasing the pulmonary treatment device from a delivery device;allowing the tissue to maintain the increased distance.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of enhancing a breathing efficiency of apatient with a lung having an airway, the method comprising: advancing atreatment device distally through the airway to a portion of the lung ofthe patient while the treatment device is in a delivery configuration,the treatment device having a proximal end and a distal end; deployingthe treatment device in a portion of the lung by transitioning thetreatment device from the delivery configuration to a deployedconfiguration, the deployed configuration of the treatment devicecomprising at least two helical sections with a transition sectiondisposed between the at least two helical sections; wherein thetransition section is configured to straighten lung tissue disposedbetween the at least two helical sections when the device is in thesecond configuration.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of enhancing a breathing efficiency of apatient with a lung having an airway, the method comprising: advancing atreatment device distally through the airway to a portion of the lung ofthe patient while the treatment device is in a delivery configuration,the treatment device having a proximal end and a distal end; deployingthe treatment device in a portion of the lung by transitioning thetreatment device from the delivery configuration to a deployedconfiguration, the deployed configuration of the treatment devicecomprising at least two helical sections with a transition sectiondisposed between the at least two helical sections; wherein the distalend is configured to straighten lung tissue disposed more distal to theat least two helical sections when the treatment device is transitionedto the deployed configuration.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of enhancing a breathing efficiency of apatient with a lung having an airway, the method comprising: advancing atreatment device distally through the airway to a portion of the lung ofthe patient while the treatment device is in a delivery configuration,the treatment device having a proximal end and a distal end; deployingthe treatment device in a portion of the lung by transitioning thetreatment device from the delivery configuration to a deployedconfiguration, the deployed configuration of the treatment devicecomprising at least two helical sections with a transition sectiondisposed between the at least two helical sections; wherein the distalend is configured to straighten lung tissue disposed more distal to theat least two helical sections when the treatment device is transitionedto the deployed configuration.

In another aspect of the present invention, a lung treatment method isprovided, comprising the steps of enhancing a breathing efficiency of apatient with a lung having an airway, the method comprising: advancing atreatment device distally through the airway to a portion of the lung ofthe patient while the treatment device is in a delivery configuration,the treatment device having a proximal end and a distal end; deployingthe treatment device in a portion of the lung by transitioning thetreatment device from the delivery configuration to a deployedconfiguration, the deployed configuration of the treatment devicecomprising at least two helical sections with a transition sectiondisposed between the at least two helical sections; wherein the distalend is configured to straighten lung tissue disposed more distal to thedistal end when the treatment device is transitioned to the deployedconfiguration and the proximal end is repositioned more proximally,relative to the deployed distal end.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a delivery device having a proximal end, adistal end and lumen therethrough, wherein the distal end is configuredto be advanced through a tracheobronchial tree of the lung to an area ofloose damaged alveolar sac tissue; a pulmonary treatment deviceadvanceable through the lumen of the delivery device, wherein thepulmonary treatment device includes a tissue gathering end and astabilizing end; a deployment element removably attached to thepulmonary treatment device and insertable into the lumen of the deliverydevice, wherein together the delivery device and deployment element 1)deploy the tissue gathering end into the area of loose damaged alveolarsac tissue while maintaining attachment of the pulmonary treatmentdevice to the deployment element, 2) pull the deployed tissue gatheringend so as to re-tension the area of loose damaged alveolar sac tissue,and 3) deploy the stabilizing end within a lung passageway so as tomaintain the re-tension of the area of loose damaged alveolar sactissue.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a delivery device having a proximal end, adistal end and lumen therethrough, wherein the distal end is configuredto be advanced through a tracheobronchial tree of the lung to an airwayin the lung; a deployment sleeve comprising a distal end and a proximalend and a lumen therethrough which is sized to be advanced through thedelivery device lumen, a guidewire which may be passed through the lumenof the deployment sleeve; a pulmonary treatment device having a distaltissue gathering end, a proximal stabilizing end and a midsection springelement that is mounted around the outside of the delivery device in aconfiguration that allows the system to be advanceable through thetrachea and into lung airways and lung passageways, wherein thepulmonary treatment device is configured to be advanced so that theproximal stabilizing end is wedged into lung tissue; the delivery deviceis configured to continue to advance the non-stabilizing portion of thetreatment device so that the midsection spring element is strained to alonger state; the deployment sleeve is configured to be advanced andheld against distal end of the treatment device to hold it in place inthe patient while the delivery device is removed. The system includes aguidewire which is configured to hold the treatment device aligned inthe same axis as the delivery device lumen. The delivery device may be abronchoscope.

In another aspect of the present invention, a system is provided fortreating a COPD patient's lung comprising: a delivery system elementwith a distal end, a proximal end and a lung treatment device configuredto at least partially encircle the delivery system element while thesystem is used to treat a patient.

In another aspect of the present invention, a system is provided fortreating a COPD patient's lung comprising: a delivery system elementwith a distal end, a proximal end and a length which is longer than 2times the largest transverse dimension of the element, a lung treatmentdevice configured to at least partially encircle the delivery systemelement while the system is advanced into a patient.

In another aspect of the present invention, a system is provided fortreating a COPD patient's lung comprising: a delivery system elementwith a distal end, a proximal end and a length which is longer than 2times the largest transverse dimension of the element, a lung treatmentdevice configured to at least partially encircle the delivery systemelement while the system is advanced into a patient to deliver thetreatment device to a treatment location in the lung.

In another aspect of the present invention, a system is provided fortreating a COPD patient's lung comprising: a delivery system elementwith a distal end, a proximal end and a length which is longer than 2times the largest transverse dimension of the element, a lung treatmentdevice configured to at least partially encircle the delivery systemelement while the system is advanced into a patient to deliver thetreatment device to a treatment location in the lung.

In another aspect of the present invention, a system is provided fortreating a COPD patient's lung comprising: a delivery system canula witha distal end, a proximal end and a length which is longer than 2 timesthe largest transverse dimension of the canula, a lung treatment deviceconfigured to at least partially encircle the delivery system canulawhile the system is advanced into a patient to deliver the treatmentdevice to a treatment location in the lung, whereas the lung treatmentdevice is implanted in the lung to enhance lung elastic recoil.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a delivery system canula with a distal end,a proximal end and a length which is longer than 2 times the largesttransverse dimension of the canula, a pulmonary treatment deviceconfigured to at least partially encircle the delivery system canulawhile the system is advanced into a patient to deliver the treatmentdevice to a treatment location in the lung, whereas the treatment deviceis implanted in the lung to tension lung tissue.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a bronchoscope with a distal end, a proximalend and a length which is longer than 2 times the largest transversedimension of working length portion of the bronchoscope, a pulmonarytreatment device configured to at least partially encircle thebronchoscope while the system is advanced into a patient to deliver thetreatment device to a treatment location in the lung, whereas thetreatment device is implanted in the lung to treat COPD.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a bronchoscope with a distal end, a proximalend and a length which is longer than 2 times the largest transversedimension of working length portion of the bronchoscope, a pulmonarytreatment device configured to at least partially encircle thebronchoscope while the system is advanced into a patient to deliver thetreatment device to a treatment location in the lung, whereas thetreatment device is implanted in the lung to treat the symptoms relatingto COPD.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a bronchoscope with a distal end, a proximalend and a length which is longer than 2 times the largest transversedimension of working length portion of the bronchoscope, a pulmonarytreatment device configured to at least partially encircle thebronchoscope while the system is advanced into a patient to deliver thetreatment device to a treatment location in the lung, whereas thetreatment device is implanted in the lung to by making one or more ofthe beneficial changes in the patient that are listed herein above.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a bronchoscope with a distal end, a proximalend and a length which is longer than 2 times the largest transversedimension of working length portion of the bronchoscope, a pulmonarytreatment device configured to at least partially encircle thebronchoscope while the system is advanced into a patient to deliver thetreatment device to a treatment location in the lung, whereas thetreatment device is elongated before it is implanted in the lung to makeone or more of the beneficial changes in the patient that are listedherein above.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a bronchoscope with a distal end, a proximalend and a length which is longer than 2 times the largest transversedimension of working length portion of the bronchoscope, a pulmonarytreatment device configured to at least partially encircle thebronchoscope while the system is advanced into a patient to deliver thetreatment device to a treatment location in the lung, whereas thetreatment device is elongated to store elastic strain energy to bereleased in tissue to make one or more of the beneficial changes in thepatient that are listed herein above.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a bronchoscope with a distal end, a proximalend and a lumen miming therethrough, a pulmonary treatment deviceconfigured to at least partially encircle the bronchoscope while thesystem is advanced into a patient to deliver the treatment device to atreatment location in the lung, whereas the treatment device iselongated to store elastic strain energy to be released in tissue tomake one or more of the beneficial changes in the patient that arelisted herein above.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a bronchoscope with a distal end, a proximalend and a lumen running therethrough, a pulmonary treatment deviceconfigured to at least partially encircle the bronchoscope while thesystem is advanced into a patient to deliver the treatment device to atreatment location in the lung, whereas the treatment device iselongated to store elastic strain energy to be used to tension lungtissue.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a bronchoscope with a distal end, a proximalend and a lumen running therethrough, a pulmonary treatment deviceconfigured to at least partially encircle the bronchoscope while thesystem is advanced into a patient to deliver the treatment device to atreatment location in the lung and a bronchoscope guide sleeve with adistal end, a proximal end and a lumen configured to allow thebronchoscope to be advanced through the bronchoscope guide sleeve;whereas the treatment device is elongated by the bronchoscope guidesleeve and the bronchoscope to store elastic strain energy in thetreatment device to be used to tension lung tissue.

In another aspect of the present invention, a system is provided fortreating a lung comprising: a pulmonary treatment device, a bronchoscopeand a bronchoscope guide sleeve whereas the treatment device isconfigured with a proximal end, a distal end and a midsection and alumen running through the treatment device proximal end and midsectionalong the central axis between the distal end and the proximal ends, thebronchoscope guide sleeve is configured with a proximal end, a distalend and an open lumen running through the full length of thebronchoscope guide sleeve along the central axis between the distal endand proximal end; the bronchoscope is configured to be advanced throughthe bronchoscope guide sleeve and through the proximal end andmidsection of the lung treatment device so the treatment device lengthmay be adjusted by sliding the bronchoscope guide sleeve along the axisof the coaxial bronchoscope.

In another aspect of the present invention, a system is provided fortreating a lung comprising: an assembly for straightening a portion of alung airway, the assembly comprising:

a straightening element; a first end configured for fixing to a firstportion of the lung, the straightening element attached to the firstend; a second end configured for fixing to a second portion of the lung,the straightening element being attached to the second end; a deliverydevice for delivering the first end to the first portion of the lung andfor delivering the second end to the second portion of the lung.

In another aspect of the present invention, a system is provided fortreating a lung comprising: an assembly for straightening a portion of alung airway, the assembly comprising:

a straightening element; a first end configured for fixing to a firstportion of the lung, the straightening element attached to the firstend; a second end configured for fixing to a second portion of the lung,the straightening element being attached to the second end; a deliverydevice for delivering the first end to the first portion of the lung andfor delivering the second end to the second portion of the lung; whereasthe delivery device is a bronchoscope.

In another aspect of the present invention, a system is provided fortreating a lung comprising: an assembly for straightening a portion of alung airway, the assembly comprising:

a straightening element; a first end configured for fixing to a firstportion of the lung, the straightening element attached to the firstend; a second end configured for fixing to a second portion of the lung,the straightening element being attached to the second end; a deliverydevice for delivering the first end to the first portion of the lung andfor delivering the second end to the second portion of the lung; whereasthe delivery device is a tube.

In another aspect of the present invention, a system is provided fortreating a lung comprising: an assembly for straightening a portion of alung airway, the assembly comprising: a straightening element; a firstend configured for fixing to a first portion of the lung, thestraightening element attached to the first end; a second end configuredfor fixing to a second portion of the lung, the straightening elementbeing attached to the second end; a delivery device for delivering thefirst end to the first portion of the lung and for delivering the secondend to the second portion of the lung; whereas the straightening elementis tensioned after at least one end is deployed.

In another aspect of the present invention, a system is provided fortreating a lung comprising: an assembly for straightening a portion of alung airway, the assembly comprising: a straightening element; a firstend configured for fixing to a first portion of the lung, thestraightening element attached to the first end; a second end configuredfor fixing to a second portion of the lung, the straightening elementbeing attached to the second end; a delivery device for delivering thefirst end to the first portion of the lung and for delivering the secondend to the second portion of the lung; whereas the straightening elementand ends are made more co-axial before being released from the deliverydevice than they are while being delivered to the airway.

In another aspect of the present invention, a system is provided fortreating a lung comprising: an assembly for straightening a portion of alung airway, the assembly comprising: a straightening element; a firstend configured for fixing to a first portion of the lung, thestraightening element attached to the first end; a second end configuredfor fixing to a second portion of the lung, the straightening elementbeing attached to the second end; a delivery device for delivering thefirst end to the first portion of the lung and for delivering the secondend to the second portion of the lung; whereas the first end is adeformable spring.

In another aspect of the present invention, a system is provided fortreating a lung comprising: an assembly for straightening a portion of alung airway, the assembly comprising: a straightening element; a firstend configured for fixing to a first portion of the lung, thestraightening element attached to the first end; a second end configuredfor fixing to a second portion of the lung, the straightening elementbeing attached to the second end; a delivery device for delivering thefirst end to the first portion of the lung and for delivering the secondend to the second portion of the lung; whereas the second end is adeformable spring.

In another aspect of the present invention, a system is provided fortreating a lung comprising: an assembly for straightening a portion of alung airway, the assembly comprising: a straightening element; a firstend configured for fixing to a first portion of the lung, thestraightening element attached to the first end; a second end configuredfor fixing to a second portion of the lung, the straightening elementbeing attached to the second end; a delivery device for delivering thefirst end to the first portion of the lung and for delivering the secondend to the second portion of the lung; whereas the straightening elementis a helix.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the delivery device is a bronchoscope

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the delivery device is a tube.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the first straightening element is tensioned after atleast one end is deployed.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the first straightening element and first end is made moreco-axial before being released from the delivery system than they arewhile being delivered to the airway.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the second straightening element and second end is mademore co-axial before being released from the delivery device than theyare while being delivered to the airway.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the first tissue gathering end is a deformable spring.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the first straightening element is a helix.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the second straightening element is a helix.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the connector that connects the first straighteningelement to the second straightening element is a v shaped spring.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; whereas the connector that connects the first straighteningelement to the second straightening element is a v shaped spring.

In another aspect of the present invention, a system is provided forstraightening more than one lung airway, the assembly comprising: afirst straightening element having a first end for attaching to a firstairway in the lung; a second straightening element having a second endfor attaching to a second airway in the lung; a connector that connectsthe first straightening element to the second straightening element; anda delivery device for delivering the first end to the first airway inthe lung and for delivering the second end to the second airway in thelung; additionally, more components may be included to be used tostraighten a 3rd or 4th, 5th or 6th airway with a single device.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart a straightening force on a lung airway, the implantable deviceincluding a proximal end, and a distal end with a transition sectionconnecting the two ends that includes at least one helical loopstructure; furthermore, the device has a first delivery configurationand a second deployed configuration, the first configuration of theimplantable device corresponds to a deliverable length constrainedcondition, the second configuration is configured so the distancebetween the start and end of at least one of the helical loop structurercan be increased to straighten the airway.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein atleast one of the ends comprise a circular helical section when theimplantable device is in the second configuration.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; whereinboth of the ends comprise a circular helical section when theimplantable device is in the second configuration.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein theimplantable device further comprises a jacket (jacket can be metallic,plastic, coating, coil or extrusion made from a variety of materials,such as metals (e.g. stainless steel, titanium, nitinol, nickel, cobaltchrome, or a combination of these) or polymers (e.g. polycarbonateurethane, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene(ETFE). fluorinated ethylene propylene (FEP), polyimide film (e.g.Kapton®), polyimide, polyether ether ketone (PEEK), polyethylene,ethylene-vinyl acetate (EVA) (also known as poly (ethylene-vinylacetate) (PEVA)), polypropylene, polyvinyl alcohol (PVA), polyurethane,nylon, polyether block amides (PEBA), acrylonitrile butadiene styrene(ABS), polybutyrate, butyrate, polyethylene terephthalate (PET),polysulfone (PES), ethylene tetrafluoroethylene (ETFE), polyvinylidenefluoride (PVDF), thermoplastic polyurethane elastomers (e.g.Pellethane®), aliphatic polyether-based thermoplastic polyurethanes(TPUs) (e.g. Tecoflex®), metallocenes or a combination of these) whichcovers a portion of the implantable device, the jacket configured toreduce erosion into the airway by a deployed implantable device (bymaximizing the bearing area in contact with the tissue to be greaterthan 9.81E-7 inches squared of bearing area per linear inch of theimplantable device).

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein ajacket covers the at least one helical sections.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein ajacket covers the distal end of the implantable device.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein thedistal end of the implantable device is configured to couple with theairway.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein theproximal end of the implantable device is atraumatic.

A method for treating a lung of a patient, the lung including a lungpassageway system having a first lung passageway elongate axial regionwith an associated first local lung passageway central axis and a secondlung passageway elongate axial region with an associated second locallung passageway central axis, the method comprising: introducing anelongate body of an implant system axially into the lung passagewaysystem so that a proximal portion of the elongate body is disposedwithin the first axial lung passageway region and so that a distalimplant portion of the elongate body is disposed within the second axiallung passageway region; tensioning a lung tissue volume disposed atleast in part distal to at least one of the lung passageway axialregions by bending the elongate body between the proximal and distalportions so as to urge the first local lung passageway axis of the firstlung passageway axial region laterally toward the second lung passagewayaxial region while the proximal and distal portions of the elongate bodyextend axially within the first and second lung passageway axialregions, respectively.

A method for treating a lung of a patient, the lung including a lungpassageway system having a first lung passageway elongate axial regionwith an associated first local lung passageway central axis, and asecond lung passageway elongate axial region with an associated secondlocal lung passageway central axis, the method comprising: introducingan elongate body of an implant system axially into the lung passagewaysystem so that a proximal portion of the elongate body is disposedwithin the first axial lung passageway region and so that a distalimplant portion of the elongate body is disposed within the second axiallung passageway region; tensioning a lung tissue volume disposed atleast in part distal to at least one of the lung passageway axialregions by releasing strain energy that has been previously stored inthe elongate body to compress the elongate body between the proximal anddistal portions so as to urge the first local lung passageway axis ofthe first lung passageway axial region laterally toward the second lungpassageway axial region while the proximal and distal portions of theelongate body extend within the first and second lung passageway axialregions, respectively.

A method for treating a lung of a patient, the lung including a lungpassageway system having a first lung passageway elongate axial regionwith an associated first local lung passageway central axis, and asecond lung passageway elongate axial region with an associated secondlocal lung passageway central axis, the method comprising: introducingan elongate body of an implant system axially into the lung passagewaysystem so that a proximal portion of the elongate body is disposedwithin the first axial lung passageway region and so that a distalimplant portion of the elongate body is disposed within the second axiallung passageway region; tensioning a lung tissue volume by releasingstrain energy that has been previously stored in the elongate body so asto urge the first local lung passageway axis of the first lungpassageway axial region laterally toward the second lung passagewayaxial region while the proximal and distal portions of the elongate bodyextend axially within the first and second lung passageway axialregions, respectively.

A method for treating a lung of a patient, the lung including an lungpassageway system having a first lung passageway elongate axial regionwith an associated first local lung passageway central axis, and asecond lung passageway elongate axial region with an associated secondlocal lung passageway central axis, the method comprising: introducingan elongate body of an implant system axially into the lung passagewaysystem so that a proximal portion of the elongate body is disposedwithin the first axial lung passageway region and so that a distalimplant portion of the elongate body is disposed within the second axiallung passageway region; tensioning a lung tissue volume by rotating theelongate body.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein theproximal end of the implantable device comprising one or more featuresselected from the following: a ball, loop, break away link, threadedhole or shaft, friction fit taper or hole, that is reversibly coupled toa delivery system.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein theimplantable device is made of a metal alloy that contains nickel andtitanium.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein theimplantable device is made from a stainless-steel alloy.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein theimplantable device is made from a steel alloy containing chromium.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein theimplantable device is made from an alloy containing cobalt.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein thestabilizing end comprises more helical loops than the tissue gatheringend when the implantable device is in the second configuration.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein thetissue gathering end comprises less than one loop when the implantabledevice is in the second configuration.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein thehelical section transitions into the proximal end via a bend that isdisposed between the proximal portion of the helical section and theproximal end such that the helical section is straightened when proximalend is repositioned more proximally relative to the proximal portion ofthe helical section when the device is in the second configuration.

In another aspect of the present invention, a lung airway straighteningsystem is provided for enhancing breathing efficiency of a patient withan airway, the system comprising: an implantable device configured toimpart tension on lung tissue, the implantable device including aproximal stabilizing end, and a distal tissue gathering end with atransition section connecting the two ends that includes at least onehelical loop structure with a start and an end to the helical loop;furthermore, the device has a first delivery configuration and a seconddeployed configuration, the first configuration of the implantabledevice corresponds to a deliverable condition and a finite distancebetween the start and end of at least one of the helical loopstructures, the second configuration is configured so the distancebetween the start and end of the same helical loop structures may beelastically strained longer to apply tension to lung tissue; wherein theimplant comprises a spring element and wherein the implant isconstrained to the delivery configuration during delivery and whereinthe implant is configured to naturally recover from the constraineddelivery configuration to the deployed configuration during deployment.

In another aspect of the present invention, a lung tensioning device isprovided that tensions lung tissue with the application of a rotatingmotion to turn the implant after a portion of the implant has engagedtissue.

In another aspect of the present invention, a lung tensioning device isprovided that tensions lung tissue with the application of a combinationof rotating motion and longitudinal translation motion to turn theimplant and to apply longitudinal translation of the implant after aportion of the implant has engaged tissue.

These and other embodiments are described in further detail in thefollowing description related to the appended drawing figures.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 illustrates a healthy lung of a patient.

FIGS. 2-3 illustrates damaged lung tissue.

FIG. 4 illustrates a cross-sectional slice under computed tomography(CT) of the lungs of a patient suffering from COPD.

FIG. 5 illustrates a lung of a patient suffering from advanced COPD.

FIG. 6 illustrates an embodiment of a pulmonary treatment devicecomprising an elongate shaft coiled into a helical shape to form atissue gathering end, a stabilizing end and an extendable midsectiontherebetween.

FIG. 7 illustrates an embodiment of the pulmonary treatment deviceexpanding along its longitudinal axis.

FIG. 8 illustrates a pulmonary treatment device delivered by a deliverydevice configured to be advanced to an area of loose damaged alveolarsac tissue.

FIG. 9 illustrates retraction of the deployment element whichstraightens and extends the surrounding airway.

FIG. 10 illustrates the pulmonary treatment device left in place tomaintain re-tensioning of the lung.

FIG. 11 illustrates the positioning of three pulmonary treatment deviceswithin the lung of a patient.

FIG. 12 illustrates a plurality of pulmonary treatment devicespositioned in both lungs of a patient.

FIG. 13 illustrates an embodiment of a tissue gathering end of apulmonary treatment device.

FIG. 14 illustrates a top view of the embodiment of FIG. 13 .

FIG. 15 illustrates another embodiment of a tissue gathering end of apulmonary treatment device.

FIG. 16 illustrates a top view of the embodiment of FIG. 15 .

FIG. 17 illustrates an embodiment of a tissue gathering end of apulmonary treatment device having multiple loops.

FIG. 18 illustrates a top view of the embodiment of FIG. 17 .

FIG. 19 illustrates another embodiment of a tissue gathering end of apulmonary treatment device.

FIG. 20 illustrates a top view of the embodiment of FIG. 19 .

FIG. 21 illustrates an embodiment of a tissue gathering end wherein theshaft extends along the longitudinal axis through the extendiblemidsection and then gradually bends radially outwardly distal to theextendible midsection.

FIG. 22 illustrates a top view of the embodiment of FIG. 21 .

FIG. 23 illustrates an embodiment of a tissue gathering end wherein atleast one of the loops of the tissue gathering end cross at least aportion of another loop.

FIG. 24 illustrates a top view of the embodiment of FIG. 23 .

FIG. 25 illustrates an embodiment of a pulmonary treatment device havingan extendible midsection connecting the tissue gathering end with thestabilizing end.

FIG. 26 illustrates an embodiment of a pulmonary treatment device havingan attachment feature located distally of the stabilizing end.

FIGS. 27A-27D illustrate example tips suitable for either the distal tipor proximal tip.

FIGS. 28A-28D illustrate example methods of forming the tips of FIGS.27A-27D.

FIGS. 29A-29D illustrate example tips having an attachment feature.

FIG. 30 illustrates an embodiment of a device configured from a shaftcomprising a hollow tube.

FIGS. 31A-31B illustrate an embodiment of a bronchoscope used as adelivery device for delivering the pulmonary treatment device.

FIG. 32 illustrates an embodiment of an introducer having a pre-loadedpulmonary treatment device.

FIG. 33 illustrates another embodiment of an introducer having apre-loaded pulmonary treatment device.

FIG. 34 illustrates a pre-loaded introducer advanceable into the workingchannel port of a bronchoscope.

FIG. 35 illustrates the insertion cord tip of the bronchoscopepositioned in the damaged tissue of the patient's lung.

FIGS. 36-37 illustrate an embodiment wherein two devices are joined withthe use of a joining device.

FIG. 38 illustrates an embodiment of a delivery system for delivering apulmonary treatment device of the present invention.

FIG. 39 illustrates an embodiment of a pulmonary treatment device thatis deliverable by the system of FIG. 38 and has a flared stabilizingend.

FIG. 40 illustrates the treatment device of FIG. 39 mounted on thedelivery system of FIG. 38 .

FIG. 41 illustrates deployment of the treatment device within the targetairway by advancing the delivery system so as to push the tissuegathering end further along the target airway while the extendiblemidsection expands, elongating the treatment device.

FIG. 42 illustrates the beginning stages of decoupling the device fromthe delivery system wherein the tissue gathering end is unmounted fromthe bronchoscope.

FIG. 43 illustrates further steps of decoupling the device from thedelivery system, wherein the deployment sleeve and guidewire have beenremoved from the bronchoscope allowing the tissue gathering end to fullyengage with the wall of the airway.

FIG. 44 illustrates retraction and removal of the delivery device fromthe lung anatomy, leaving the treatment device behind.

FIG. 45 illustrates the treatment device after the stored elastic strainenergy that has been stored in at least the midsection of the treatmentdevice has urged the device to shorten and recover elastically moreclosely to its original pre-elongated length.

FIG. 46 illustrates another embodiment of a delivery system for deliveryof a treatment device, the delivery system comprises a bronchoscopehaving a bronchoscope body and an insertion cord, a guidewire, adeployment sleeve and a guide sleeve.

FIG. 47 illustrates an embodiment of a treatment device releasablymounted on the delivery system of FIG. 46 . FIG. 48 illustrateselongation of the extendible midsection due to retraction of thestabilizing end by the guide sleeve and catch feature.

FIG. 49 illustrates another embodiment of a treatment device, whereinthe treatment device has a tissue gathering end and extendiblemidsection which is similar to the device of FIG. 39 , however in thisembodiment the stabilizing end differs.

FIG. 50 illustrates the treatment device of FIG. 49 loaded onto adelivery system.

FIG. 51 illustrates deployment of the tissue gathering end of thetreatment device of FIG. 49 within an airway.

FIG. 52 illustrates extension of the midsection of the treatment deviceof FIG. 49 by retracting the guide sleeve which has a tether extendingtherethrough removably attached to the extension loop of the device.

FIG. 53 illustrates anchoring of the stabilizing end of the treatmentdevice of FIG. 49 by retracting the bronchoscope from the device.

FIG. 54 illustrates the treatment device of FIG. 49 after the tether hasbeen cut and removed, thereby allowing the midsection to recoil towardits natural configuration over time.

FIG. 55 illustrates the elastic recoil of the treatment device of FIG.54 supporting the airway tree A, B, C, D, E and F in tension.

FIG. 56 illustrates an alternative method of treating a patient whereinthe pulmonary treatment device is deployed in the lung anatomy and thenexpanded thereafter.

FIG. 57 illustrates an embodiment of a treatment device that iscollapsible into a small profile for optional delivery through a lumenin a delivery device.

FIG. 58 illustrates the treatment device of FIG. 57 in a collapsedconfiguration mounted on a guidewire.

FIG. 59A illustrates the treatment device in a non-stressedconfiguration

FIG. 59B illustrates the treatment device and delivery system in a lungwith the treatment device partially deployed in the lung

FIG. 60 illustrates a treatment device and delivery system whereas thetreatment device is partially deployed in the lung and the tissuegathering end of the treatment device is being rotated to apply torqueto lung tissue to tension the lung tissue

FIG. 61 illustrates the treatment device deployed in the lung after thetissue gathering end has been rotated to apply toque to tension lungtissue and the anchoring end has been deployed in another airway branchto maintain the torsion and lung tissue tension

FIGS. 62A-62D illustrate the treatment device and delivery system withsequential deployment steps including rotation motions applied to thetissue gathering end and deployment of the anchoring end to maintain thetissue gathering, rotation and tensioning.

FIG. 63A-63C illustrates embodiments of treatment devices with a varietyof tissue gathering and anchoring element shapes.

FIG. 64 illustrates an embodiment of a treatment device with a tissuegathering element that crosses over the longitudinal axis of the device.

FIG. 65 illustrates an embodiment of a treatment device made from tworibbon strips that have been bonded together.

FIG. 66 illustrates an embodiment of a treatment device that has beencrimped together.

FIG. 67 illustrates an embodiment of a treatment device with acurvilinear tissue gathering element.

FIG. 68 illustrates an embodiment of a treatment device with matchingtissue gathering and anchoring elements.

FIG. 69 illustrates an embodiment of a treatment device with strainrelief sections that store energy during deployment.

FIGS. 70A-70B illustrates an embodiment of a treatment device comprisedof a tube having slots or cuts along at least a portion of its length toincrease bearing area against tissue.

FIG. 71A-71C illustrates alternative designs to increase device bearingarea on tissue.

FIG. 72 illustrates an embodiment of a treatment device with aexpandable anchoring element design.

FIG. 73 illustrates an embodiment of a treatment device with hooks asanchoring elements.

FIG. 74 illustrates an embodiment of a treatment device with a stent asan anchoring element.

FIG. 75 illustrates an embodiment of a treatment device section madefrom two joined wires.

FIG. 76A-76B illustrates embodiments of treatment device attachment endconfigurations.

FIG. 77 illustrates an embodiment of a treatment device socketingattachment end.

FIG. 78 illustrates an embodiment of a treatment device threadedattachment end.

FIG. 79 illustrates an embodiment of a treatment device with aninterlocking attachment end.

FIG. 80 illustrates an embodiment of a treatment device attachment endthat is controlled by forceps.

FIG. 81 illustrates an embodiment of a treatment device with a stentanchoring element.

FIGS. 82A-82B illustrates an embodiment of a treatment device made froma single wire shaft.

FIGS. 82C-82D illustrate additional embodiments of a pulmonary treatmentdevice having a tissue gathering element and an anchoring element.

FIGS. 82E-82G illustrate steps in an example method of deploying atorque-based pulmonary treatment device such as illustrated in FIGS.82A-82D.

FIGS. 83A-831 illustrates an embodiment of a treatment device beingdeployed in lung tissue.

FIG. 84A-84E illustrates an embodiment of a dual tissue gatheringelement treatment device and components.

FIG. 85 illustrates an embodiment of a treatment device and deliverysystem inserted into an airway.

FIG. 86 illustrates an embodiment of a treatment device tissue gatheringelements deployed through the airway wall.

FIG. 87 illustrates an embodiment of a treatment device being rotated torotate and tension tissue.

FIG. 88 illustrates an embodiment of a treatment device middle sectionbeing deployed from the catheter.

FIG. 89 illustrates an embodiment of a treatment device anchoring endbeing deployed to the airway ostium.

FIG. 90 illustrates an embodiment of a treatment device being decoupledfrom the delivery system control devices.

FIGS. 91A-91D illustrate design details of an embodiment of a torqueingtool and connection.

FIG. 92 illustrates steps of an embodiment of a method that includesbasic treatment steps that utilize torque to affect tissue.

FIG. 93 illustrates an example of two treatment devices deployed intoadjacent airways.

FIG. 94 illustrates steps of an embodiment of a method to deploy twotreatment devices in branching airways.

FIG. 95 illustrates steps of an embodiment of a method to deploy atreatment device while seeking anatomical feedback.

FIG. 96 illustrates steps of an embodiment of a method to deploy atreatment device while seeking physiologic feedback.

FIGS. 97A-97C illustrates an embodiment of a torsion-based treatmentdevice that is surgically installed.

FIG. 98 illustrates the treatment device of FIG. 97A surgicallyinstalled.

FIGS. 99A-99D illustrate embodiments of distal tips having twisted ends.

FIG. 100 illustrates an embodiment of a torque-based pulmonary treatmentdevice prepared for pre-loading in an introducer.

FIG. 101 illustrates the device of FIG. 100 preloaded into theintroducer and prepared for advancement into a catheter.

FIG. 102 illustrates the distal tip of the catheter of FIG. 101 advancedbeyond the distal tip of the bronchoscope and the beginning steps ofdeployment of the device.

FIG. 103 illustrates exposure of the anchoring element for anchoring ofthe device.

FIG. 104 illustrates expansion of the anchoring element.

FIG. 105 illustrates release of the device to be left behind as animplant.

FIG. 106 illustrates an embodiment of such a pulmonary treatment devicecomprising a clip having a first arm and a second arm.

FIGS. 107A-107C illustrate an embodiment of the clip of FIG. 106 in use.

FIG. 108 illustrates a plurality of clips used to treat a targetlocation having a plurality of airways branching from an ostium.

FIG. 109 illustrates example treatment of a plurality of targetlocations within a lung wherein each target location comprises a triplebranching airway from a single ostium.

FIG. 110 illustrates an embodiment of a clip having a proximal end thatincludes a strain relieving loop.

FIG. 111 illustrates an embodiment of a clip having a proximal end thatincludes a strain relieving loop and arms that are curved rather thanstraight.

FIGS. 112A-112B illustrate a branched airway having an entwined bloodvessel and an embodiment of a clip having a gap.

FIG. 113 illustrates an embodiment of a clip having arms with a varietyof curves, some of which are symmetrical about a longitudinal axis andsome of which are not.

FIG. 114 illustrates an embodiment of a clip having magnets.

FIG. 115 illustrates an embodiment of a clip having pointed tips at theends of the arms.

FIG. 116 illustrates an embodiment of a clip having tips that are bluntand spring loaded for strain relief

FIG. 117 illustrates the embodiment of the clip being delivered with theuse of a delivery device.

FIG. 118 illustrates the clip of FIG. 117 fully deployed within thebifurcation.

FIGS. 119-121 illustrate embodiments of clips wherein the arms havediffering lengths and/or shapes from each other.

FIG. 122 illustrates the clip of FIG. 121 positioned at a bifurcation.

FIG. 123 illustrates an embodiment of a delivery device having adeployment device that is coupleable to a clip in a manner that allowstransmission of torque to the clip by rotation of the deployment device.

FIG. 124 provides a close-up view of an embodiment of a deploymentdevice that is coupleable to a clip in a manner that allows transmissionof torque.

FIG. 125 illustrates an embodiment deployment device having a window ofa spiral shape.

FIG. 126 illustrates an embodiment of a deployment device similar toFIG. 124 , however here the hitch wire has a configured proximal end anddistal end.

FIG. 127 illustrates an embodiment of an invertible pulmonary treatmentdevice emerging from a delivery device.

FIG. 128 illustrates an embodiment of an invertible pulmonary treatmentdevice that is similar to that illustrated in FIG. 127 .

FIG. 129 illustrates another embodiment of an invertible pulmonarytreatment device.

FIG. 130 illustrates yet another embodiment of an invertible pulmonarytreatment device.

FIG. 131 illustrates a branched lung passageway comprising a firstairway that extends into damaged tissue, along with a delivery devicepositioned therein.

FIG. 132 illustrates an early step in a process of deployment of aninvertible pulmonary treatment device wherein the distal tips haveemerged from the distal end of the delivery device.

FIG. 133 illustrates tissue gathering elements extending into damagedtissue and holding elements grasping damaged tissue.

FIG. 134 illustrates an invertible pulmonary treatment device that hasbeen pulled so that the tissue gathering elements have inverted.

FIG. 135 illustrates an embodiment of an anchoring element deployed byretraction of a delivery device and optionally a bronchoscope.

FIG. 136 illustrates an embodiment of an invertible pulmonary treatmentdevice decoupled from a delivery device, revealing an attachmentfeature.

FIG. 137A illustrates another embodiment of an invertible pulmonarytreatment device.

FIG. 137B illustrates a variation of the embodiment of FIG. 137A whereinthe inversion elements curve radially outwardly away from thelongitudinal axis and each other.

FIG. 138 provides a side view of the invertible pulmonary treatmentdevice of FIG. 137A

FIGS. 139A-139D illustrate an embodiment of a delivery system of aninvertible pulmonary treatment device.

FIG. 140 illustrates the insertion cord tip of the bronchoscope insertedinto a lung passageway, wherein the distal end of the catheter extends ashort distance from the bronchoscope and the guidewire extends into thelung anatomy.

FIG. 141 illustrates the catheter advanced further into the workingchannel of the bronchoscope so that the distal end of the catheter isadvanced further.

FIG. 142 illustrates the catheter inserted into the working channel ofthe bronchoscope so that its proximal end emerges from the workingchannel

FIG. 143 illustrates an embodiment of an invertible pulmonary treatmentdevice reaching the distal end of the catheter.

FIG. 144 illustrates an embodiment of an invertible pulmonary treatmentdevice as it is emerged further from the catheter.

FIG. 145 illustrates further advancement of the tissue gatheringelements into damaged tissue, wherein their pre-curvature bends distaltips toward the proximal direction.

FIG. 146 illustrates still further advancement of the tissue gatheringelements into the damaged tissue wherein their pre-curvature bendsdistal tips back around toward the distal direction.

FIG. 147 illustrates emerging of the inversion elements from the distalend of the catheter.

FIG. 148 illustrates the catheter and plunger having been pulledtogether in the proximal direction.

FIG. 149 illustrates the anchoring element released from the plunger.

FIG. 150 illustrates the inversion elements having been recovered towardits original pre-formed shape

FIG. 151 illustrates the inversion elements have fully retracted to itsoriginal pre-formed shape.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the disclosed device, delivery system, andmethod will now be described with reference to the drawings. Nothing inthis detailed description is intended to imply that any particularcomponent, feature, or step is essential to the invention.

Anatomical Changes in COPD

FIG. 1 illustrates a healthy lung L of a patient. As shown, the lung Lincludes a tracheobronchial tree which is the anatomical and functionalsegment of the respiratory system that conducts air from the largerupper airways to the lung parenchyma. It is comprised of the trachea Tand various intrapulmonary airways, including the bronchi, bronchiolesand terminal bronchioles. The trachea and bronchi have cartilaginouswalls which makes them thick, fibrous and this allows them to maintainpatency during breathing Bronchi undergo multiple divisions andeventually give rise to the terminal bronchioles, which by definition,lack cartilage. The most distal respiratory bronchioles and alveoli arewhere gas exchanges into and out of the blood stream.

The trachea T is also referred to as the zero-generation airway and itextends distally 10-12 cm and it then divides into the right and leftmainstem bronchi MB, commonly referred to as the first-generationairways. The left mainstem bronchus MB (shown in FIG. 1 ) is about 5 cmin length. The mainstem bronchus MB divides into the lobar bronchi LB(secondary or second-generation airways) and subsequently into thesegmental bronchi SB (tertiary or third generation). Subsegmentalairways (fourth generation airways) branch off from the segmentalairways and they lead to the numerous subsegmental portions that arefound in each lobar segment. Bronchi undergo multiple divisions (onaverage 23) along the bronchial tree. The initial 16-17 generations ofbronchi make up the conducting zone of the airways and these do notnormally participate in gas exchange in healthy lungs. However, with theprogression of COPD and particularly with Emphysema, many of thetraditional pathways beyond about the fourth generation commonly getdestroyed and collateral pathways are formed that allow gas tocommunicate and get trapped in places in the lung that can no longerexchange gas as well as alveolar tissue in the lung that can exchangegas.

As bronchi divide into smaller airways, the respiratory epitheliumundergoes histological changes and gives rise to terminal bronchioles.The 17th to 19th generations of bronchioles constitute the transitionalzone. These bronchioles enter pyramid-shaped pulmonary lobules separatedfrom one another by a thin septum, with the apex directed toward thehilum, comprising 5-7 terminal bronchioles. The last 2-3 generations ofbronchioles have some alveoli in their walls and make up the respiratoryzone. The area of the lung that is distal to a terminal bronchiole istermed the acinus. The final division is called the respiratorybronchiole, which further branches into multiple alveolar ducts.Alveoli, the functional units of the respiratory system, start appearingat the level of the respiratory bronchioles. This is where the majorityof gas is exchanged. It is important to note that the majority of thehealthy lung volume is comprised of alveoli tissue. The airway networkbranches from the trachea through the various portions of the lung tosupply a volume of oxygen and to expel carbon dioxide from alveoli thatare positioned almost everywhere within the lung. Only a small volume ofthe lung is occupied by the airway tree and the arterial network thattransports blood from the right side of the heart through the lung tothe left side of the heart.

In a healthy lung L, the intrapulmonary airways are held open by tensiont (indicated by lines with facing arrows) between the airways and thechest wall CW. The elastic nature of healthy connective lung tissue andalveoli tissue communicates the tension. The tension is required to holdairways open during normal breathing as the airways experience higherexternal pressure, relative to the internal air pressure, duringexhalation breathing cycles. Without this radial outward lung elasticrecoil tension holding the airways open, the airways would collapseduring exhalation which would not allow air to exit the lung. The lung Lis suspended in an expanded state due to negative pressure or vacuumbetween the chest wall CW and the exterior lining of the lung, or pleuraPL, of the lung L. As a person inhales, the chest wall CW and ribs R areexpanded by the chest wall muscle CWM and the diaphragm muscle Dcontracts to lower the diaphragm and reduce the diaphragm arch DA whichexpands the lung L and its volume. By expanding the volume, a negativepressure is created in the alveoli which draws fresh oxygen into theairways and alveoli. Such expansion causes the interior lung tissue tobe stressed with increased tension which dilates the airways andincreases lung elastic recoil. This increased lung elastic recoilgreatly enhances alveoli and airway contraction during exhalation. Thisability to stretch and undergo extreme elastic strain elongation withthe ability to fully recoil back to an original shape is made possibleby a fibrous protein called elastin. Elastin fibers are present invirtually all vertebrate tissues, although it is only found in abundancewithin a few structures, such as arteries, some ligaments, and the lung.In these organs, elastin comprises an appreciable percentage of thetotal protein.

In many respects, elastin is a perfectly designed protein for its rolein normal lung function. The unusual amino acid composition and lysinederived crosslinks provide the elastin fiber with great distensibilityand recoil properties. They also lend chemical stability to the fiber,which is susceptible to few proteolytic enzymes and chemical injuries.Complications arise in conjunction with this inherent stability. Matureelastin has an extremely low turnover rate. Once the delicatearchitecture of the alveolar walls has been constructed and thecontinuum of connective tissue fibers is established, the components aremeant to remain in that configuration. After the fetal and earlyperinatal stages of lung development there is no ability to initiate anew and architecturally correct alveolus if the original structure hasbeen destroyed.

The introduction of tobacco smoke and other pollutants signalsmacrophages and neutrophils to respond. As the neutrophils degranulateand release their enzymes there is disparity between the finely tunedratio of elastase to antiprotease which perpetuates destruction of thelung tissue and lung elastic properties. Every injury sustained byalveolar elastin that is not repaired hastens the inevitable cleavage ofthe alveolar wall. If the injury is perpetuated, as is the case withcigarette smoke, alveolar walls are slowly cleaved, leaving greatlyenlarged air spaces and a lung without elastic recoil properties.Coalescence of damage leaves structural gaps in the tissue that furtherreduces the lungs ability to maintain tissue integrity and lung elasticrecoil properties.

FIGS. 2-3 illustrate this change in lung composition. As the alveolarsacs are destroyed, large open spaces form called pulmonary blebs,bullae and giant bullae which can exceed several centimeters in length,width or length. Pulmonary blebs are small subpleural thin walled aircontaining spaces, not larger than 1-2 cm in diameter. Their walls areless than 1 mm thick. Pulmonary bullae are, like blebs, cystic airspaces that have an imperceptible wall (less than 1 mm). The differencebetween blebs and bullae is generally considered to be their size, withthe cross-over being around 2 cm in diameter. Blebs may, over time,coalesce to form bullae or giant bullae. FIG. 2 illustrates damage thatis typically seen in patients with early stage of severe emphysema whileFIG. 3 is more typical of tissue that would be seen in a late stageemphysema patient who would typically present with 30% annual mortalityrate. FIG. 4 illustrates a cross-sectional slice acquired using computedtomography (CT) of the lungs of a patient suffering from COPD. CT is anoninvasive, painless procedure that uses low-dose x-ray images tovisualize the lung tissue. As shown, a large portion of the lungparenchyma has been destroyed and the majority of the lungs are nowmostly air pockets, consisting of blebs and bullae.

FIG. 5 illustrates a lung L of a patient suffering from advanced COPD.As in most COPD sufferers, this example shows homogenous destruction ofthe lung parenchyma. This can be easily identified by the fact thatthere is a similar amount of damage in the upper, middle and lowerportion of the lung. If only the upper most portion of the lung wasdamaged, it would be considered a lung with heterogeneous upper lobepredominant damage. Predominant damage in the lower portion would beheterogeneous lower lobe predominant. Some patients present withheterogeneous disease but it may be upper lobe predominant in one lungand lower lobe predominant in the other lung but the vast majority ofheterogenous patients present with upper lobe damage in both lungs orlower lobe damage in both lungs. Over 60% to 75% of all patients presentwith homogenous disease with a generally even distribution of damagethroughout the lung volumes. Visible damage in some patients may be notbe easily visible, even utilizing high resolution CT images where theimage slice thickness is less than 1.0 mm thick. However, most patientspresent with damage that can be easily seen in these images such as thepockets BU shown in FIG. 5 . There is vast tissue destruction beyond the4^(th) generation airways wherein diffuse blebs BL and bullae BU fillthe area of the lung L. Thus, late stage COPD sufferers often do nothave any anatomically normal airways past the 4^(th) generation. This isa discovery based on the review of thousands of three-dimensionallyreconstructed computed tomography files that were acquired to studysevere emphysema patient's lungs. Basic medical and specializedpulmonology education teachings indicate that medium to smallcollagenous walled airways are preserved in late stage emphysemapatients and this is simply not true. CT reconstructions are typicallyreferred to as post processed CT files that show more than justtwo-dimensional visual images of cross-sectional slices of the lung.These detailed images of the inner structures of the body can bereconstructed (post-processed) in a three-dimensional format so tissuedensity and changes of density can reveal lung tissue condition,anatomical boundaries as well as physiologic data and dimensions. Thisdata can be analyzed to summarize anatomical and physiologic changessuch as airway lumen diameter change during breathing and airway volumechange. Post processing can also be used to measure the volume anddensity of blood vessels that remain intact in damaged lungs. This isparticularly useful to determine the over-all gas exchange activity inlobes or regions of the lung. Regions of lung tissue that trap gas orotherwise don't exchange oxygen and CO2 efficiently experienceaccommodation which is vascular contraction that prevents the flow ofblood that is not being properly prepared to be sent back into thevascular system. By using post processing software, it's possible tomeasure dynamic and static blood volumes in lungs, lobes and segments toevaluate where to treat the patient, recommended dose and to determineif additional treatments may be required later to maintain the patientsbreathing mechanics. Effective treatment recruits additional bloodvolume where it is otherwise insufficient or lower than typicallyphysiologically normal. Post processing can also measure airway volumewithin areas of the lung during the respiration cycle. The volume duringinspiration can be compared to the volume during expiration and themagnitude of airway collapse can be calculated by subtracting thedifference. This is a good indicator of where air trapping occurs and italso indicates where lung elastic recoil is suboptimal as the elasticrecoil is what normally holds the airways patent with volume. Areas witha greater difference in airway volume during the breathing cycle needtreatment more than areas with less.

Emphysema related destruction severely reduces lung elastic recoil andit eliminates or dramatically reduces gas exchanging tissue surfacearea. The reduction of lung elastic recoil leads to airway collapseduring exhalation, air trapping and hyperinflation. As previouslymentioned, lung elastic recoil and its associated outward radial pullingis necessary to hold airways open during exhalation as the externalpressure on and around the airways are higher than the internal airwaypressure. With reduced lung elastic recoil, the outward radial pullingon the airway is reduced and the airway collapses during exhalation. Airis still allowed to enter the lungs during inhalation but no air isallowed to flow out during exhalation. This leads to classic airtrapping and hyperinflation. The lung volume may increase but thepatients breathing capacity is reduced due to the lack of flow of freshoxygen. With these patients undergoing any form of exercise, the airwayscollapse and trap air in the lung due to diminished tension t (indicatedby wavy lines with facing arrows) between the airways and the chest wallCW. The air trapping and resulting increase in lung volume increasespressure on the heart H and the coronary arteries C. This in turn canlead to increased blood pressure, increased heart rate and decreasedblood ejection fraction from the heart to the patient's arterial system.

It may be appreciated that in some instances there is no obvious visualsign of tissue destruction in low or high-resolution CT images, howeverthere may still be numerous uniform small pockets of damage throughoutthe parenchyma which can reduce the surface area of the alveoli andtherefor reduce gas exchange by as much as 50% or sometimes more. Inaddition, there can be severe damage to the elastin and loss of lungelastic recoil without the presence of destruction that can be seen inCT images in the form of blebs, bullae or other visual indicators ofbulk enzymatic tissue destruction. This renders a normal looking lungdysfunctional due to airway collapse during breathing, etc. Mostpatients, however, present with a combination of symptoms that indicatea reduction of lung elastic recoil and also present with lung tissuedamage that can be seen in CT image reconstructions.

Treatment Overview

Methods, systems and devices are provided which take into account thevast tissue damage of advanced COPD sufferers and provides treatmentdesigned specifically to treat the particularly compromised lung tissuesthat are present in these patients. Such tissue damage has not beenidentified or acknowledged by previous treatment plans which has led toinsufficient treatment and undesired outcomes in many cases. Inparticular, in some embodiments, the degree of tissue damage is assessedand the locations that the damage manifests in a lobe or lobes isutilized in the determination of the treatment plan. Thus, the extentand distribution of tissue damage is utilized in determining the numberof devices that may be desired to treat the patient and the most optimallocations that the devices should be placed. These same data may also beused to assess the patient over time to determine if more devices shouldbe implanted at the same locations as was targeted in a previousprocedure to enhance or restore the improvement brought on in the firstprocedure or if implants might be best deployed in new locations thatwere not previously treated in order to restore the benefit brought onby an original treatment. In some embodiments, damage that can be seenby looking at CT image file reconstructions or post-processed CT imagefiles is used as an indicator for loss of tissue recoil properties,compromised blood vessel communication or perfusion, hyper-inflation,air trapping, airway lumen collapse, clogged or congested airways. Theextent and distribution of such tissue loss is determined by a varietyof comparisons, such as comparisons between upper and lower lobes,comparisons between volumes of affected tissue per lobe, and comparisonsof areas of destruction per CT slice integrated across number of slices.In some embodiments, damage is quantified by analyzing CT files (CTpost-processing) and used to plan treatment or dose of therapeuticimplant. For example, in some embodiments, such analysis of CT filesutilizes software that analyzes and compares CT scans and summarizeddetailed physiologic data that is acquired during a patient'sinspiration portion of a breath versus data acquired during expiration,to measure the change in density and additional metrics which indicatedegree of airway collapse, blood flow patterns through the breathingcycle, locations of trapped air, regional lung volume changes, lobarlung volume changes, total lung volume changes, diaphragm motion,vectors of motion and displacement of motion of various regions of thelung which can be used to evaluate levels of compliance in the lungs orregions of the lungs. Areas with high compliance (large magnitudes oftissue displacement during breathing) need treatment to restore elasticrecoil force that reduces compliance.

Blood vessel volume and total blood volume within a lung, lobe, segmentand sub-segments can be calculated using CT data files andpost-processing technology. Since blood vessels contract where oxygentransfer is less than normal (below physiologic levels, commonly calledblood vessel accommodation) blood volume reduction or signals such asdata indicating that blood volume is lower than normal can be used todetermine where lung elastic recoil needs to be improved, where theairways are collapsing and trapping air, where lung elastic recoil issuboptimal, where enzymatic activity is high and many other things thatwould indicate that the devices should be placed in those regions.Differences between lobes of more than 10% blood volume is significantand less blood volume indicates more damage has been done by thedisease. Changes of more than 10% of lobar blood volume over timeindicates significant ongoing destruction and this signals a target forminimally invasive therapy such as the treatment described herein.Successful treatment increases the lobar blood volume in most cases.Pre-treatment versus post treatment CT analysis that indicates anincrease of lobar blood volume of 5% or more is considered significant.

In some instances, CT images that are acquired during inhalation andothers acquired during exhalation can be compared to determine whatregions or lobes experience the greatest amount of volume expansion andcontraction. High levels of motion and relative volume change indicatesthat these regions perform with a high level of compliance. Again, areaswith high compliance is a target where treatment can benefit thepatient. Computational CT analysis may be performed to measure therelative change in position of thousands of easily identifiable pointsin the lungs such as the many Corina branch points of the blood vesselsand airways during inhalation versus exhalation. If the distance between2 points moves more than the rest of the points in the lung (on % basisor gross length change), the region between the points is more compliantthan other regions in the lung. Additionally, the compliant regions maycomprise elongated and slack tissue so the distance between the twopoints move freely during chest expansion. It may be appreciated thatslack tissue is typically referred to as high compliance or highcompliance tissue. High compliance is a strong indicator of slack tissuewith low tissue elasticity and patients will benefit from placement ofdevices that incorporate strong spring elements where the compliance ishighest. Thus, devices may be deployed in parts of the lung that are themost compliant as these devices are designed to reduce compliance tobring the patients lung breathing mechanics closer to physiologicbreathing performance.

In some instances, CT images are acquired while the patient inhales andothers acquired while the patient exhales wherein they are compared todetermine what regions or lobes experience air trapping. The volume ofthe lungs, lobes, segments or even sub-segments of a lobe may bemeasured using CT quantitative analysis to measure these volumes duringinhalation and compare to the same region during exhalation. If thevolume of a region, as measured while the patient exhales, is less than40% of the measured volume of the same region while the patient inhales,the region is considered to be not trapping air. However, if the exhalevolume is more than 40% of the volume of the same region while thepatient inhales, the region is considered to be trapping air. This is astrong indicator that the lung elastic recoil in the region has beencompromised and the tissue requires therapy to increased tissuetensioning. The total volume of lung that is measured that traps airindicates how much dose the patient needs. For instance, therapy isrecommended if the patient is found to trap air in 50 cc's of lungvolume or more. Therapy that reduces more than 50 cc's of lung volumeimproves breathing and this can be measured using any of the measurableoutcomes listed herein. The therapy devices described herein providelung volume reduction of at least 50 cc. The therapies described hereinmay provide at least a 50 cc reduction of lung volume that traps air, asmeasured by quantitative CT analysis. The device embodiments describedherein are typically designed to provide at least 10 cc of volumereduction or reduction of lung that traps air. Again, areas with highcompliance trap air during exhale and present a measurable andquantitative parameter to use as a threshold to indicate treatment, torecommend therapy dose and such areas also provide a target to determinewhere treatment should be placed to most beneficially treat the patient.

If the patient presents with homogenous destruction, the pulmonarytreatment devices can be delivered to the most severely damaged regions,if they can be identified, or the devices can be delivered to everymajor lobe so as to tension the entire lung system uniformly. If thepatient presents with strongly heterogenous destruction, the pulmonarytreatment devices can be delivered to low attenuation (low density) orhigh compliance areas of the lung, commonly the two upper lobes only.These areas exchange gas less efficiently and therefore present as lowerrisk locations to place implants rather than always placing devices inall lobes, in order to preserve maximum lung and breathing capacity.Devices may also be placed in high attenuation portions of the lung(high density tissue) to gain additional traction if the low attenuationportions are so destroyed that there is minimal to no tissue for thedevice to engage. This is possible because the devices restore theairway lumens and minimal tissue is being compromised with deviceplacement. If this is done, the high-density tissue that has asignificant amount of preserved elastic recoil will not easily expand orelongate with tension but the entire region of relatively preservedtissue will simply be pulled to a new location and the adjacent lowattenuation tissue with low elastic recoil properties will still betensioned. Sometimes this involves pulling an entire lobe to a newposition and using the negative pressure in the fissure that separatethe lobes to communicate the tension to another lobe. This allowstension and lung elastic recoil to be enhanced or created in places thatmay not be ideal for implant placement. Device placement and tensioningalso lifts the diaphragm to restore basic diaphragm movement to enhancebreathing mechanics. By deploying the device in a lung to causetensioning, the lowest compliance tissues that are connected in a serialfashion will be strained more than the higher compliance areas and thelung tissue will be brought to equilibrium with more uniform complianceand elastic recoil performance. This strain also pulls airways radiallyoutward and holds them open so they cannot collapse during exhaleevents. This reduces air trapping in the lung tissue.

Once the type and extent of damage has been accessed, the treatment planis devised, including choice and placement of various treatment devicesof the present invention designed specifically for use in damaged lungtissue.

FIG. 6 illustrates an embodiment of a pulmonary treatment device 10 ofthe present invention. In this embodiment, the device 10 comprises anelongate shaft 12 coiled into a helical shape to form a tissue gatheringelement or tissue gathering end 14, an anchoring element or stabilizingend 16 and an extendable midsection 18 therebetween. Typically, each end14, 16 is comprised of 1-2 coil turns, however any suitable number ofturns may be used. The pulmonary treatment device 10 is configured toexpand along a longitudinal axis 19, as illustrated in FIG. 7 , whereinthe bulk of the expansion occurs along the extendable midsection 18. Insome embodiments, the device 10 has a diameter of 2-50 mm and a lengthof 0.25-10 inches, preferably 0.5-1 inch, in resting free space. In suchembodiments, the device 10 typically has a potential longitudinalelongation of between 0.25 and 10 inches, but most preferably 2-4 inchesof potential elongation beyond the devices original length. However, thedimensions of the device 10 after deployment in the body may vary due toconstraints of the airways and pattern of disease. Devices 10 deployedinto smaller airways will have smaller diameters due to anatomicalconstraints. Likewise, the extension of the midsection 18 may varydepending on the location of the target treatment site within thetracheobronchial tree. A brief overview of deployment will be providedfollowed by a more detailed description of various elements andfeatures.

The pulmonary treatment device 10 is sized and configured to bedelivered by a delivery device configured to be inserted into the lung,such as a steerable scope (e.g. bronchoscope 20), such as illustrated inFIG. 8 . In some embodiments, the pulmonary treatment device 10 isconfigured to be delivered through a lumen in the delivery device, suchas by pushing the treatment device through a lumen of a scope, catheter,introducer, sheath, sleeve or similar device. In other embodiments, thepulmonary treatment device 10 is configured to be delivered by mountingit on the outside of a delivery device, such as on the outside of ascope, catheter (e.g. a balloon catheter), introducer, sheath, sleeve,guidewire or similar device. In some embodiments, when mounting on theoutside of a delivery device, the treatment device 10 freely slide alongthe length of the delivery device. It may be appreciated that thepulmonary treatment device 10 may be configured to be delivered using acombination of these delivery device components such as mounting thetreatment device 10 on a guidewire or balloon catheter shaft anddelivering the assembly through the channel of the bronchoscope. It maybe appreciated that when using a guidewire, the delivery system may beconfigured to be Over-The-Wire (OTW) or Rapid Exchange (RX) wherein theguidewire exits the delivery system at a particular location for theconfiguration. For example, in an OTW design, the guidewire exits thedelivery system at its proximal end so that the guidewire that tracksalong the full length of the delivery device. In contrast, in the RXdesign, the guidewire only tracks along a short section (about 25 cm) ofthe delivery device and then exists at a side port. This design savestime compared with advancing a guidewire through the full length of thedelivery device.

In some embodiments, the device 10 is loaded into a bronchoscope port 22and the bronchoscope 20 is advanced through the tracheobronchial tree toa target location within the lung. In patients with advanced COPD, lungtissue and airways are inflamed, bleed easily and react to even slighttrauma, such as by advancement of a guidewire or catheter. Therefore,unlike conventional endobronchial valves and coils, in theseembodiments, the device 10 may be deliverable without the use of aguidewire and/or catheter. In this embodiment, the device 10 is loadedwithin the bronchoscope port 22 so that the tissue gathering end 14 isdirected distally. The bronchoscope 20 is then steered through theairways AW atraumatically, without digging its distal tip into theairway walls W. Typically, the distal end of the bronchoscope 20 isadvanced into or well beyond the 4^(th) generation airways, often intothe areas of the lung containing highly damaged tissue DT. This iseasily accomplished when the bronchoscope outer diameter is less than4.5 mm diameter. This is typically a bronchoscope with a 2.0 mm diameterchannel and port. In these areas of damaged tissue, large portions ofparenchyma are often loose or missing, forming coalesced blebs andbullae. Thus, normal lung passageways with supportive walls aretypically not available, and any existing tissue is sponge-like and veryweak. The tissue gathering end 14 of the pulmonary treatment device 10is deployed in this damaged tissue DT, as illustrated in FIG. 8 . Thisis typically achieved by advancement of a deployment element 30 thatextends through the bronchoscope port 22 or by retraction of thebronchoscope 20 while the deployment element 30 maintains its positionrelative to the damaged tissue DT. The deployment element 30 comprisesan elongate shaft 32 having an attachment mechanism 36 near its distalend. The attachment mechanism 36 engages an attachment feature 38 on thedevice 10 so as to maintain connection between the deployment element 30and the device 10 during deployment. In this embodiment, the attachmentfeature 38 comprises a loop 40 formed by the shaft 12 of the device 10.The loop 40 is disposed near or within the stabilizing end 16, as moreclearly illustrated in FIGS. 6-7 . Referring back to FIG. 8 , in thisembodiment, the attachment mechanism 36 comprises a tether 42 (e.g.suture, metallic wire (such as comprised of stainless steel, titanium,nitinol or other nickel based alloy), monofilament or multifilamentfiber, braid, polymer or ceramic or glass fiber (such as comprised ofKevlar®, carbon fiber, nylon, polyurethane, polypropylene or otherdurable material)) and a support rod 44 (such as comprised of polymer,metal, ceramic or another durable material). The tether 42 extendsthrough the loop 40 and around the support rod 44 so as to secure theloop 40 to the support rod 44. Thus, the stabilizing end 16 of thedevice 10 is able to remain attached to the deployment element 30 duringdeployment by the attachment mechanism 36. It may be appreciated thatother attachment features 38 include a ball, a breakaway link, athreaded hole or shaft, or a friction fit taper or hole, to name a few.

In some embodiments, as the tissue gathering end 14 is released into thearea of loose damaged DT, the tissue gathering end 14 expands androtates, gathering up the loose, damaged tissue in a manner that fixedlyengages the end 14 with the damaged tissue DT. In other embodiments, thetissue gathering end 14 expands and dilates the airway or passagewaythrough the damaged tissue DT so as to be effective in gathering tissuewhen the tissue gathering end 14 is pushed or pulled longitudinallyalong the axis 19. Once the tissue gathering end 14 has fixedly engagedwithin the damaged tissue DT, the deployment element 30 is retractedinto the bronchoscope port 22. Since the deployment element 30 isattached to the attachment feature 38 of the device 10, such retractiontugs the device 10. This causes extension of the midsection 18 andpulling of the damaged tissue DT engaged by the tissue gathering end 14.Such pulling continues until a desired level of resistance occurs or thedamaged tissue DT has been pulled a desired amount. This retraction maybe observed using an integrated bronchoscope camera or using one of manypossible forms of X-ray imaging and equipment such as real timefluoroscopic imaging, fluoroscopic CT (computed tomography), biplaneX-ray or other methods. The retraction and tissue gathering magnitudemay be measured by observing the distance that the tissue gatheringfeature is moved. In some embodiments, movement in a range of 1 cm to 25cm, preferably 7-8 cm, indicates substantial and adequate gathering oftissue and axial pulling to cause lung tissue tensioning to increaselung elastic recoil. Pulling force of 0.005 to 0.30 pounds force arebeneficial to the patient but preferably 0.01-0.20 pounds force areapplied to the tissues of the lung. The deployment element 30 is thenadditionally retracted which further extends the midsection 18. Thisstraightens and extends the surrounding airway AW, as illustrated inFIG. 9 . By observing the increased length of the midsection 18, usingimaging methods, the user can observe and adjust the amount of lengthchange imparted on the midsection which will ensure adequate recoilenergy is stored in the midsection 18 of the device 10. It is importantto store potential energy in the device 10 so it remains in tension tocontinue to enhance lung elastic recoil, even if the lung tissue relaxesand elongates over time. Retraction of the deployment element 30continues until the stabilizing end 16 reaches a suitable airway forholding and maintaining the stabilizing end 16. Typically, thedeployment element 30 is retracted until the stabilizing end 16 ispositioned within an ostium OS or point of branching within thetracheobronchial tree. The larger diameter of the ostium OS allows thestabilizing end 16 to expand and exert stabilizing radial force againstthe walls W of the ostium OS, holding the expanded device 10 in place.If the midsection 18 is not desirably elongated, such as 1-5 cm longerthan it presents prior to retraction of the stabilizing end 16, thedevice may be recaptured and redeployed more distally so the midsection18 may be elongated enough to preserve the treatment effect over time.Once the stabilizing end 16 is secured within the airway AW, theattachment mechanism 36 is released from the attachment feature 38. Inthis embodiment, the tether 42 is severed which allows removal from thesupport rod 44. The tether 42 is then removed along with the support rod44. The bronchoscope 20 is then removed, along with the deploymentelement 30, leaving the device 10 in place, as illustrated in FIG. 10 .

Since the device 10 remains in an expanded configuration, the coiledconfiguration holds potential energy and creates tension between thedamaged tissue DT and the ostium OS. This newly acquired tensionreplaces the loss of tension caused by COPD. Thus, the airway AW andtissue that is more distal and more proximal to the device 10 isre-tensioned, providing renewed recoil strength. This improves breathingand reduces air trapping and resultant hyperinflation which is common inadvanced COPD. In addition, the stored potential energy providescontinued tension as the damaged tissue DT and/or airway AW naturallyrelaxes due to progression of COPD. Thus, such re-tensioning continueseven during disease progression.

Thus, the pulmonary treatment device 10 provides a variety of featureswhich improve lung function and quality of life for COPD sufferers,particularly those in advanced stages with few treatment options. Sincethe device 10 has a coiled configuration with an open central lumen, thedevice 10 does not obstruct airflow when implanted. This is in contrastto many of the existing implantable devices used to treat COPD, such asendobronchial valves. Such valves are intended to obstruct the airway,blocking off a portion of the lung so as to mimic LVRS. Thus, anyfunctioning alveolar sacs are obstructed and are unable to be used. Incontrast, the pulmonary treatment device 10 maintains access to thedamaged tissue DT so that remaining functioning alveolar sacs can beutilized. The ends 14, 16 of the device 10 are coaxially biased so thatpositioning of the device 10 within a tortuous airway naturallystraightens the airway AW along the longitudinal axis 19 of the device10. In addition, the elongation of the midsection 18 of the device 10,elongates the airway AW providing a more direct pathway with lessresistance to airflow. This is in contrast to endobronchial coils whichare intended to bend and fold airways, compressing tissue and creatingresistance to airflow. This blocks off regions of the lung so as tomimic LVRS.

In addition, at least some portions of the coiled configuration areradially expandable. Thus, the pulmonary treatment device 10 acts in astent-like manner, supporting airway walls W and improving airflow. Inaddition to providing tensioning of the lung tissues to radially pull onairways to maintain patency during exhalation (when airway collapse iscommon in these patients), the stenting feature of the pulmonarytreatment device internally supports the inside diameter of the airwaysto maintain patency during breathing. The act of deploying the device 10(thereby re-tensioning the airways) holds the small airways, that aresmaller than 2.0 mm in diameter, open, further increasing airflow. Thisact also displaces lung tissue closer to the trachea and pulls tissuefarther from the pleura, shifting lung tissue closer to the heart. Thetrachea and central airways, such as the first, second, third and fourthgeneration airways, are much better reinforced by a pulmonary treatmentdevice configured to be anchored in airways comprising mostly cartilageas compared to airways beyond the 4^(th) generation so the tissuescloser to the heart function as a foundational support for device 10. Asthe device 10 is elongated and anchored in the reinforced supportregion, the distal tissue gathering end 14 can efficiently pull andtension tissue that lies between the tissue gathering end 14 and thechest wall. Most of the lung volume adjacent to the chest wall comprisessmall airways and alveoli. This is a particularly fertile region toretention in order to improve breathing mechanics as a large percentageof air trapping happens in the beds of small airways (commonly referredto as small airways disease). The coiled configuration provides aspring-like or resilient quality to the device 10 during breathingDuring inhalation, the device 10 lengthens or elongates, and, duringexhalation, the device 10 shortens or contracts. This ability to changedimension during breathing while maintaining relatively uniform tensionlevels in the lung allows device 10 to behave similar to normal healthylung tissue. The tension does not dramatically change during the breathcycle.

It is important to point out that this type of lung elastic recoilenhancing treatment device 10 can beneficially be made from a singlecontinuous element such as a single length of wire or fiber. This singleelement design enjoys the benefit of not comprising joints or links thatmay fail due to strain or bending during the high number of breathingcycles the device may encounter during the remainder of the patient'slife. The single element may be made with varying diameter sections orit can be made from tapered diameter material as well as material thathas totally non-uniform size or cross section along its length. A singlecomponent implant design is ideal. The treatment device 10 may also bemade from a number of components if different diameter shaft material orif different materials are desired in the different sections such as themid-section versus the stabilizing end or the mid-section versus thetissue gathering end. The mid-section is most ideal if it's made fromresilient material whereas the tissue gathering distal end 14 and thestabilizing proximal end 16 may be made from more rigid material. Thedifference in modulus between the two portions may be as much as 500% ormore different and they would still be suitable. A single componentstructure may be configured with tuned material properties in differentlocations of the single element. Nitinol material may be adjusted byusing local heat treatment techniques to increase or decrease thestiffness or modulus of elasticity in local portions of the wire. Thisis beneficial in that the tissue gathering ends may be tuned to be stiffto be most effective to engage tissue and the central spring portion maybe tuned to be less stiff to be ideally matched with the stiffness ofhealthy lung tissue.

It may be appreciated that any number of pulmonary treatment devices 10may be positioned within a lung of a patient. FIG. 11 illustrates thepositioning of three pulmonary treatment devices 10 a, 10 b, 10 c withinthe lung L of a patient P. As shown, a bronchoscope 20 is advanced downthe trachea T and into the bronchial tree of the lung L. A firstpulmonary treatment device 10 a is loaded within a port 22 and thebronchoscope 20 is advanced through the airways of the bronchial tree toa first area of damaged tissue DT1. The first pulmonary treatment device10 a is deployed as described above so that the first area of damagedtissue DT1 is drawn toward the trachea T and lung tissue in the vicinityis re-tensioned. The bronchoscope 20 may then be retracted and removedfrom the patient P. This allows the bronchoscope 20 to be cleansed so asto avoid transferring bacteria and contaminating other airways whenre-introducing the bronchoscope 20. The second pulmonary treatmentdevice 10 b is then loaded within the port 22 and the bronchoscope 20 isadvanced through the airways of the bronchial tree to a second area ofdamaged tissue DT2. The second pulmonary treatment device 10 b isdeployed as described above so that the second area of damaged tissueDT2 is drawn toward the trachea T and lung tissue in the vicinity isre-tensioned. The bronchoscope 20 may then again be retracted andremoved from the patient P. Again, the bronchoscope 20 may be cleansedand third pulmonary treatment device 10 c is loaded within the port 22and the bronchoscope 20 is advanced through the airways of the bronchialtree to a third area of damaged tissue DT3. The third pulmonarytreatment device 10 c is deployed as described above so that the thirdarea of damaged tissue DT3 is drawn toward the trachea T and lung tissuein the vicinity is re-tensioned. The bronchoscope 20 is then retractedand removed from the patient P. Alternatively, the bronchoscope 20 maybe left in the lung throughout the delivery of the three devices 10 a,10 b, 10 c through the bronchoscope channel to the locations shown inFIG. 11 . Or, the devices 10 a, 10 b, 10 c may be delivered into thelung via a catheter that has been advanced through the bronchoscopechannel. As many as 25 devices may be placed within each lobe. Pulmonarytreatment devices may be placed in a single lobe during a singleprocedure, in two or more lobes during a single procedure or in all 4major lobes during a single procedure. Alternatively, one, two, three or4 of the major lobes may be treated over a sequence of severalprocedures with typically 1-4 weeks of recovery time between procedures.Lastly, one or more pulmonary treatment devices may be placed in one ormore lobes during a single procedure and additional pulmonary treatmentdevices may be implanted in sequential additional procedures.

FIG. 12 illustrates a plurality of pulmonary treatment devices 10positioned in both lungs L. The devices 10 are preferably delivered intoregions of the lung with the most tissue destruction. If the patientsuffers from upper lobe predominant heterogenous disease, the upperlobes in the left and right lungs are preferably treated. If the patientsuffers from homogeneous disease where the tissue destruction is diffusethroughout every major lobe of both lungs, devices 10 are preferablyplaced in all five lobes of the lung. This “total lung” treatment isideal because each device 10 is designed to restore and preserve lungelastic recoil. Homogeneous patients need this enhancement in all majorlobes of the lung and unlike nearly every alternative treatment, thedevices 10 will not block or otherwise render lung tissuenon-functioning. By simply pulling tissue sufficiently to eliminateslack in the lung tissue and restoring lung elastic recoil withoutcompromising gas exchange function of the tissue, the devices 10 can beplaced in locations throughout the lungs to additively enhance breathingmechanics in these patients.

It may be appreciated that each pulmonary treatment device 10 may impartdiffering levels of re-tensioning in a lung L. But, overall, the impacton the lung L is such that a variety of clinical goals have beenachieved. Such goals include returning physiologic tension to make thelung perform in a more physiologic way. The human lung normally behavesin a fully elastic manner in which it expands between approximately 200milliliters with the application of pressure relating to approximately20 centimeters of H₂O or 0.02 Bar or 0.02 atmospheres and 1200milliliters with the application of 40 centimeters of H₂O pressure. Thepulmonary treatment device removes slack in the tissue, minimizes tissuecompression, restores lung elastic recoil, enhances breathing mechanicsby providing an elastic link to enhance spring properties in the tissue,radially outwardly supports airways to maintain airway lumen patency,internally stents airways to maintain lumen patency and lifts thediaphragm to restore diaphragm motion. This also increases the lumendiameter or caliber of the airways and increases the radial outwardsupport to the airways so that the support is sufficient to hold theairways open. Airway closure during expiration is delayed and the timethat airways stay open during expiration is increased. Likewise, airwayresistance is reduced along with air trapping in the lung. Suchtensioning reduces hyperinflation and the related increase in lungvolume. This has a variety of beneficial effects on the heart andcirculation, including reducing pressure on the heart becausehyperinflated lungs push on the heart, reducing pressure on coronaryarteries, reducing pulmonary artery pressure, reducing systolic and/ordiastolic blood pressure, reducing blood hypertension, reducing heartrate, increasing blood oxygen percent, decreasing CO2 levels in bloodstream and increasing blood ejection fraction as relieving lunginflation related pressure on the heart allows it to contract and refilemore efficiently. Additionally, treating patients with the pulmonarytreatment device will reduce the amount of Dyspnea, otherwise known asshortness of breath, and quality of life is improved. Quality of life isnormally measured using validated patient surveys such as SGRQ scoringsurveys. As the patient's quality of life is improved, the SGRQ surveyscore is decreased. Appropriate patients who a have been treated withthe pulmonary treatment devices described herein will typically surveywith reduced SGRQ scores of at least 1 point but more preferably areduction of 4 or more points will be experienced.

In addition, beneficial effects of pulmonary treatment in the lung canbe measured by monitoring one or more of a number of possible pulmonaryindicators, including measuring benefit by measuring increased forcedexpiratory volume during expiration, increased lung emptying duringexpiration, reduced end-expiratory lung volume, reduced functionalresidual capacity, reduced residual volume left in the lung during orafter expiration (RV), reduced volume of gas that is trapped in the lungduring or after expiration reduced volume of gas that is trapped in alobe during or after expiration, reduced dynamic hyperinflation,decrease total lung capacity, reduce RV/TLC ratio, increased tidalexpiratory volume change during tidal breathing at rest, increasedinspiratory reserve volume during tidal breathing at rest, increasedforced expiratory volume in the first second (FEV1), increased forcedvital capacity volume (FVC), and increase ratio FEV1/FVC, to name a few.

Additionally, the beneficial effects of pulmonary treatment in the lungcan be measured by monitoring one or more of the following measures,including reduced lung tissue density (e.g. more than 5 HU (Hounsfieldunits) change in average lung tissue density due to a treatmentprocedure), measuring lobar lung tissue density in which more than 2%change is measured, measuring the difference between lobes of lobardamage volume using a 950 HU filter in which the volume differencebetween lobes is reduced and a reduction of more than 3% volume ofdamaged tissue due to the treatment is significant, measuringdisplacement of more than 2 mm of fissure shift during the same portionof the breathing cycle is significant, or reduction of folds of pleurathat demarcate the lobes in the lung, decreased lung compliance,decreased compliance in lobes or regions of lung tissue, increased lungtissue compliance uniformity between upper versus lower lobes, increasedlung tissue compliance uniformity between lung lobes in a patient, andincreased lung tissue compliance uniformity between lobar segments, toname a few.

Overall, the patient typically has a variety of symptomaticimprovements, including reduced coughing (e.g. due to trapped air andmucus), increased ability to clear mucus due to passageways openinglarger and for longer periods of time, increased mobility (e.g. asmeasured by currently standard 6-min walk test), reduced inspiratoryeffort, reduced dysthymia, decreased breathing rate, reduced glottisclosure sensitivity (by clearing mucus, inflammation is reduced andcoughing is reduced), reduced incidence of respiratory failure andincrease time between COPD exacerbation events, to name a few.

Pulmonary Treatment Device Embodiments

Embodiments of the pulmonary treatment device 10 have various featuresand design elements to achieve the above described treatment effects andclinical goals. In addition, such features and design elements may havevarying alternatives, a variety of which will be set forth herein.

Overall, the pulmonary treatment device 10 has a relatively short lengthof between approximately 1 cm and 20 cm but preferably 2-3 cm in anunstrained condition so as to minimize its length within thebronchoscope 20. This allows the bronchoscope 20 to be advanced to or asclose to the target area within the lung L for deployment of the tissuegathering end 14. In some embodiments, the distal end of thebronchoscope 20 positioned at the target area and the tissue gatheringend 14 is deployed by retraction of the bronchoscope 20. Delivering thetissue gathering end 14 and allowing it to recover to its deployedconfiguration at the target area avoids pushing of the device 10 forwardwithin the lung tissue which causes tissue trauma.

Herein various aspects of the pulmonary treatment device 10 aredescribed in more detail. It may be appreciated that although a varietyof aspects and features are described, embodiments of the device 10 mayinclude any combination of these aspects and features. Likewise, someembodiments may not include all of the aspects and features described.For example, in some embodiments, the device 10 comprises a tissuegathering end 14 and a stabilizing end 16 without an extendiblemidsection 18 therebetween.

A. Tissue Gathering End

As described previously, the tissue gathering end 14 of the pulmonarytreatment device 10 is designed to be deployed into intact airways orthe damaged tissue DT, comprised of loose, sponge-like, weakened tissueand open areas of blebs and bullae, so as to effectively engage thedamaged tissue DT while minimizing any trauma. A variety of designfeatures are provided to achieve these goals. In some embodiments, thetissue gathering end 14 expands and is rotatable so as to gather up theloose, damaged tissue in a manner that fixedly engages the end 14 withthe damaged tissue DT. Thus, the tissue gathering end 14 is configuredto gather, connect or hook into as much damaged soft tissue as possible.In some embodiments, this involves rotating the tissue gathering end 14which threads the end 14 into place, such as through existing holes inthe tissue. Due to the specialized design of the tissue gathering end14, such rotation does not twist or bend airways in the lung.

FIG. 13 illustrates an embodiment of a tissue gathering end 14 of apulmonary treatment device 10 of the present invention. In thisembodiment, the tissue gathering end 14 comprises a portion of theelongate shaft 12 coiled into a helical shape, particularly having asingle coil turn to form a loop shape. In this embodiment, the shaft 12extends along the longitudinal axis 19 through the extendible midsection18 and then bends radially outwardly distal to the extendible midsection18, such as perpendicularly or at a 90 degree angle to the longitudinalaxis, forming a loop 50 in the same plane. Thus, the loop 50 has anopening 52 perpendicular to the longitudinal axis 19. FIG. 14illustrates a top view of the embodiment of FIG. 13 . Thus, asillustrated, the opening of the loop 50 is perpendicular to thelongitudinal axis 19, having a circular shape. Likewise, in thisembodiment, the loop extends nearly 360 degrees around the longitudinalaxis 19. In this embodiment, the shaft 12 has a distal tip 54 which is“turned-up” or facing in the distal direction. In some embodiments, thedistal tip 54 is aligned with the longitudinal axis 19 and in otherembodiments the distal tip 54 is offset from the longitudinal axis 19.In any case, the turned-up configuration aligns the distal tip 54 withor parallel with the direction of tension so as to avoid or reduce anytrauma to the surrounding tissue. The distal tip 54 may have a varietyof shapes including an end loop, coil, ball, bullet, tear drop, cone ortaper shape to minimize tissue trauma.

In this embodiment, the tissue gathering end 14 comprises a single loop50. However, it may be appreciated that the tissue gathering end 14 maycomprise any suitable number of loops 50 or partial loops, including aquarter loop, a half loop, a three-quarter loop, one loop, two loops,three loops, four loops, five loops, six loops, more than six loops orany combination of these. The loops 50 may have any suitable diameter,typically in the range of 10 mm to 50 mm. Each of the loops 50 may havethe same diameter or differing diameters. In some embodiments, the loopdiameters taper, such as in a funnel or cone shape, wherein loopdiameters incrementally decrease in size along the tissue gathering end14. In such embodiments, the taper may be in the distal direction or theproximal direction. In some embodiments, the tissue gathering end 14comprises a series of loops 50 having the same diameter and thentransitions into a taper, typically in the distal direction, to thedistal tip 54 or to a series of loops 50 having the same diameter whichis smaller than the loops 50 disposed proximally. In some situations,these arrangements reduce trauma to the tissue.

In some embodiments the tissue gathering end 14 comprises more than oneloop 50 to act as a spring that limits peak tensioning force on thefragile lung tissue, like a tension fuse between the tissue and theuser. Typically, total pull force applied to the tissue gathering end 14during placement of the device 10 is less than or equal to 9 Newtons. Inpreferred embodiments, the total pull force is less than or equal to 0.9Newtons but patients may utilize a range of force between 0.005 and 10Newtons but preferably near 0.07 Newtons, depending on the density ofthe tissue that is to be re-tensioned. The lower forces are required forlow density tissue and more force is required in tissue that is denserand better preserved with more lung elastic recoil. In any case, thetissue gathering end 14 is shaped to optimize contact area to reducelung tissue stress or pressure.

In some embodiments, the tissue gathering end 14 is comprised of heavygage core wire, such as core wire having a diameter of 0.10-2.5 mm butmost preferably between 0.25 mm and 0.30 mm. In some instances, thepreferred diameter depends on the shape and configuration of the tissuegathering end 14. For example, if the tissue gathering end 14 comprisesa loop shape having a diameter of less than 25 mm, the preferred corewire diameter may be 1 mm. If the tissue gathering end 14 comprises aloop shape having a diameter of greater than or equal to 25 mm, thepreferred core wire diameter may be 1-2 mm.

FIG. 15 illustrates a similar embodiment of a tissue gathering end 14 ofa pulmonary treatment device 10. In this embodiment, the shaft 12extends along the longitudinal axis 19 through the extendible midsection18 and then gradually bends radially outwardly distal to the extendiblemidsection 18. Rather than bending at a 90 degree angle to thelongitudinal axis 19, the shaft 12 bends at an angle less than 90degrees, such as a 30-45 degree angle to the longitudinal axis 19. Thiscreates an arch 56, wherein the shaft 12 then bends downward at adistance from the longitudinal axis 19 and ultimately forms a loop 50 ina plane perpendicular to the longitudinal axis 19. Thus, the tissuegathering end 14 comprises a distal facing arch 56 with a loop 50extending around the longitudinal axis 19 proximal of the arch 56. Asthe shaft 12 is retracted to tension lung tissue, arch 56 pulls loop 50down against distal tip 54 to create a shape that emulates a concentricring that gathers tissue. FIG. 16 illustrates a top view of theembodiment of FIG. 15 . As shown, the opening 52 of the loop 50 isperpendicular to the longitudinal axis 19 having a circular shape.Likewise, in this embodiment, the loop 50 extends nearly 360 degreesaround the longitudinal axis 19. In this embodiment, the shaft 12 has adistal tip 54 which is not “turned-up”; rather the distal tip 54 isdisposed in the plane of the loop 50.

FIG. 17 illustrates an embodiment of a tissue gathering end 14 of apulmonary treatment device 10 having multiple loops 50. In thisembodiment, the shaft 12 extends along the longitudinal axis 19 throughthe extendible midsection 18 and then gradually bends radially outwardlydistal to the extendible midsection 18. Again, rather than bending at a90 degree angle to the longitudinal axis 19, the shaft 12 bends at anangle less than 90 degrees, such as a 30-45 degree angle to thelongitudinal axis 19. This creates an arch 56, wherein the shaft 12 thenbends downward at a distance from the longitudinal axis 19 andultimately forms a first loop 50 a in a plane perpendicular to thelongitudinal axis 19. The shaft 12 then bends to form additional loops,such as a second loop 50 b and a third loop 50 b, each in a planeperpendicular to the longitudinal axis 19 and parallel to each other.Thus, the tissue gathering end 14 comprises a distal facing arch 56 witha plurality of loops 50 a, 50 b, 50 c extending around the longitudinalaxis 19 proximal of the arch 56. In some instances, the plurality ofloops 50 a, 50 b, 50 c allows the grabbing of more damaged tissue DT andthe entire anchor may be pulled together to bind the tissue and traptissue between the loops to cause tissue traction that wouldn'totherwise be achievable with a single loop shape. This configurationalso stores potential energy in the plurality of loops 50 a, 50 b, 50 cthat acts to maintain tissue tension even after the lung diseasecontinues with elongation of tissue over time.

FIG. 18 illustrates a top view of the embodiment of FIG. 17 . Since theloops 50 a, 50 b, 50 c have the same diameter, they are not individuallyvisible from the top view as they are overlaid. As shown, the opening 52of the loops 50 a, 50 b, 50 c are perpendicular to the longitudinal axis19 and have a circular shape. Likewise, in this embodiment, the loops 50a, 50 b, 50 c extend nearly 360 degrees around the longitudinal axis 19.Again, in this embodiment, the shaft 12 has a distal tip 54 which is not“turned-up”; rather the distal tip 54 is disposed in a plane parallel tothe planes of the loops 50 a, 50 b, 50 c.

FIG. 19 illustrates another embodiment of a tissue gathering end 14 of apulmonary treatment device 10 having multiple loops 50. In thisembodiment, the shaft 12 extends along the longitudinal axis 19 throughthe extendible midsection 18 and then gradually bends radially outwardlydistal to the extendible midsection 18. In this embodiment, the bendingis in a first direction at a 90 degree or lesser angle to thelongitudinal axis 19. The shaft 12 then bends in a second directionwhich is opposite to the first direction and ultimately bends downwardat a distance from the longitudinal axis 19 on the opposite side of theextendible midsection 18. This creates an arch 56 which straddles theextendible midsection 18. The shaft 12 then forms a first loop 50 a in aplane perpendicular to the longitudinal axis 19 and bends to formadditional loops, such as a second loop 50 b and a third loop 50 b, eachin a plane perpendicular to the longitudinal axis 19 and parallel toeach other. Thus, the tissue gathering end 14 comprises a distal facingarch 56 with a plurality of loops 50 a, 50 b, 50 c extending around thelongitudinal axis 19 proximal of the arch 56. In this embodiment, theradius of the arch 56 is such that the arch 56 extends beyond thediameter of the loops 50 a, 50 b, 50 c. This configuration resistsmovement of the arch 56 through the loops 50 a, 50 b, 50 c whilepositioning the device 10, such as when tugging on the device 10 tore-tension the lung tissue.

FIG. 20 illustrates a top view of the embodiment of FIG. 19 . Since theloops 50 a, 50 b, 50 c have the same diameter, they are not individuallyvisible from the top view as they are overlaid. As shown, the opening 52of the loops 50 a, 50 b, 50 c are perpendicular to the longitudinal axis19 and have a circular shape. Likewise, in this embodiment, the loops 50a, 50 b, 50 c extend nearly 360 degrees around the longitudinal axis 19.This top view also illustrates that the arch 56 extends beyond thediameters of the loops 50 a, 50 b, 50 c. Again, in this embodiment, theshaft 12 has a distal tip 54 which is not “turned-up”; rather the distaltip 54 is disposed in a plane parallel to the planes of the loops 50 a,50 b, 50 c.

In each of the above embodiments, the openings 52 of the one or moreloops 50 of the tissue gathering end 14 are substantially concentricwith the longitudinal axis 19. However, in other embodiments, theopenings 52 of the one or more loops 50 are not substantially concentricwith the longitudinal axis 19 and are offset from the longitudinal axis19. For example, FIG. 21 illustrates an embodiment wherein the shaft 12extends along the longitudinal axis 19 through the extendible midsection18 and then gradually bends radially outwardly distal to the extendiblemidsection 18. Rather than bending at a 90 degree angle to thelongitudinal axis 19, the shaft 12 bends at an angle less than 90degrees, such as a 30-45 degree angle to the longitudinal axis 19. Thiscreates an arch 56, wherein the shaft 12 then bends downward at adistance from the longitudinal axis 19 and ultimately forms a loop 50 ina plane perpendicular to the longitudinal axis 19. In this embodiment,the loop 50 is extends over 360 degrees but does not encircle thelongitudinal axis 19. Instead, the loop 50 is concentric with an axis 60which is parallel to the longitudinal axis 19 and offset by 3-30 mm,preferably 13 mm. FIG. 22 illustrates a top view of the embodiment ofFIG. 21 . As shown, the opening 52 of the loop 50 is perpendicular tothe longitudinal axis 19 and shifted to one side of the extendablemidsection 18. Likewise, in this embodiment, the loop 50 extends morethan 360 degrees. In this embodiment, the shaft 12 has a distal tip 54which is not “turned-up”; rather the distal tip 54 is disposed in theplane of the loop 50.

This offset configuration allows the extendable midsection 18 to bepositioned against the wall of a lung passageway rather than extendingthrough the center of the lung passageway lumen. This may reduce anypotential accumulation of mucus within the lung passageway lumen,providing an open pathway for airflow. It may be appreciated that whenthe tissue gathering end 14 is positioned within damaged tissue DT, theloop 50 is not disposed within a natural lung passageway havingstructured walls. Therefore, contact between the loop 50 and the shaft12 above the extendable midsection 18 is not problematic as the tissuegathering end 14 is not compressing the walls of a lung passageway.

In some embodiments, at least one of the loops 50 of the tissuegathering end 14 crosses at least a portion of another loop asillustrated in FIGS. 23-24 . In particular, FIG. 23 illustrates anembodiment wherein the shaft 12 extends along the longitudinal axis 19through the extendible midsection 18 and then bends radially outwardlydistal to the extendible midsection 18, such as perpendicularly or at a90 degree angle to the longitudinal axis, forming a first loop 50 a inthe same plane. Thus, the first loop 50 a has an opening 52perpendicular to the longitudinal axis 19. In this embodiment, the shaft12 continues bending circumferentially to form at least a portion of asecond loop 50 b, wherein the second loop 50 b has a smaller diameterthan the first loop 50 a. In addition, the second loop 50 b is disposedproximally to the first loop 50 a. FIG. 24 illustrates a top view of theembodiment of FIG. 23 . Thus, as illustrated, the opening of the loops50 a, 50 b are perpendicular to the longitudinal axis 19. Likewise, inthis embodiment, the second loop 50 b portion extends under the firstloop 50 a. Thus, when the device 10 is tugged in the proximal direction,during the re-tensioning step, the first loop 50 a captures the secondloop 50 b, applying the total area of the combined length of both coilstimes the width of the shaft 12 material to present a broad efficienttissue gathering anchor to be pulled in the proximal direction. Thislarge area of contact reduces the bearing pressure that is imparted onthe tissue which minimizes or eliminates the tendency for the device togrow through or migrate through the tissue over time. With minimalmigration, the advantageous effect of the treatment is prolonged. It maybe appreciated that any number of loops 50 may be present, thedistal-most loop applying force to the more proximal loops.

B. Extendable Midsection

The extendible midsection 18 connects the tissue gathering end 14 withthe stabilizing end 16, as illustrated in FIG. 25 . In some embodiments,the tissue gathering end 14, extendible midsection 18 and stabilizingend 16 are formed by shaping a single shaft to form the desiredconfigurations. However, it may be appreciated that each or some of theparts may be formed individually and joined together. In any case, themidsection 18 is configured to be extendible from at least a relaxedstate to an extended state, wherein the midsection 18 stores potentialenergy. As described previously, once the tissue gathering end 14 hasfixedly engaged the damaged tissue DT, the deployment element 30 isretracted into the bronchoscope port 22 which tugs the device 10 in theproximal direction. This causes extension of the midsection 18 andpulling of the damaged tissue DT engaged by the tissue gathering end 14.Such pulling continues until a desired level of resistance occurs or thedamaged tissue DT has been pulled a desired amount. The deploymentelement 30 is then additionally retracted which further extends themidsection 18. This straightens and extends the surrounding airway AW.Retraction of the deployment element 30 continues until the stabilizingend 16 reaches a suitable airway for holding and maintaining thestabilizing end 16. Thus, the bulk of the expansion occurs along theextendable midsection 18.

In some embodiments, the extendible midsection 18 has the shape of anelastic spring or coil. Typically, the shaft 12 is coiled into a helicalshape to form the elastic spring or coil. In some embodiments, themidsection 18 has a length in the range of 5-75 mm but preferably alength of less than 25 mm in resting free space and a potentiallongitudinal elongation in the range of 10-200 mm but preferably morethan 75 mm. However, the extension of the midsection 18 while the device10 is in use depends on the location of the target treatment site withinthe tracheobronchial tree, the extent of damage to the tissue and thedesired level of re-tensioning. In any event, in some embodiments themidsection 18 comprises at least 3 complete coils.

In some embodiments, the coiled extendible midsection 18 has a diameterin the range of 0.5-10 mm, such as 2.5 mm, particularly when the shaft12 is comprised of a wire having a diameter in the range of 0.10-0.75mm, preferably 0.25-0.3 mm. It may be appreciated that in someembodiments, the diameter of the shaft 12 forming the extendiblemidsection 18 is smaller than the diameter of the shaft 12 forming thetissue gathering end 14 or the stabilizing end 16. This may be achievedby necking down the shaft 12 in the area of the extendible midsection18, such as by grinding. In any case, the overall diameter of theextendible midsection 18 is typically smaller than both the tissuegathering end 14 and the stabilizing end 16.

In some embodiments, the extendible midsection 18 additionally supportsthe airway wall. In use, the device 10 draws the loose damaged tissue DTinward toward the lung passageways that have a maintained structure.Therefore, the extendible midsection 18 is located within an airwayhaving structured walls when the device 10 is implanted. However, suchwalls are often weakened and benefit from the additional internalsupport offered by the extendible midsection 18, particularly under thenew level of lung tensioning. As the midsection 18 of device 10 iselongated to store energy, the adjacent airway wall, along the length ofthe midsection, may be longitudinally compressed which will weaken itand possibly allow it to collapse more easily. This is more than offsetby the coil of the midsection providing radial strength and radialstenting support enough to prevent the airway, along this midsection 18length from collapsing. Likewise, the extendible midsection 18straightens the airway or the general path of the overall airway system.

In some embodiments, the extendible midsection 18 is axisymmetric withthe tissue gathering end 14 and/or the stabilizing end 16, such asillustrated in FIGS. 6-7 . In such embodiments, the midsection 18typically has an open lumen forming a tunnel to allow passage of airtherethrough. However, it may be appreciated that in some embodimentsthe extendible midsection 18 may not be axisymmetric and is disposed toone side of the tissue gathering end 14, such as illustrated in FIG. 21, and/or the stabilizing end 16. Thus, in these embodiments, themidsection 18 extends along the side of the airway (e.g. adjacent to thewall).

In some embodiments, the extendible midsection 18 is joined to a featurealong the tissue gathering end 14 to keep the tissue gathering end 14from rotating.

C. Stabilizing End

As described previously, the stabilizing end 16 of the pulmonarytreatment device 10 is designed to hold the device 10, and therefore thelung tissue, in tension by seating in an appropriate portion of thetracheobronchial tree. As mentioned, after the tissue gathering end 14has been desirably positioned, the deployment element 30 retracts andpulls the stabilizing end 16, which in turn pulls the extendablemidsection 18 and tissue gathering end 14. Such pulling continues andincreasingly applies tension to the lung, along with other physicalbenefits such as straightening the airway and increasing airflow. Oncethe stabilizing end 16 reaches a suitable airway for holding andmaintaining the stabilizing end 16, the stabilizing end 16 is seated andreleased. Typically, the stabilizing end 16 is positioned within anairway or ostium OS or point of branching within the tracheobronchialtree. The larger diameter of the ostium OS allows the stabilizing end 16to expand and exert stabilizing radial force against the walls W of theostium OS, holding the expanded device 10 in place. The end 16stabilizes the device 10, providing a base or anchor for the appliedtension which is then maintained throughout treatment of the patient asthe device 10 is left behind.

In some embodiments, the stabilizing end 16 comprises a portion of theelongate shaft 12 coiled into a helical shape, particularly havingmultiple coil turns, each having a loop shape. In some embodiments, thestabilizing end 16 comprises single loop 70, as illustrated in FIG. 25 .However, the stabilizing end 16 may have additional loops, such as twoloops, three loops, four loops or any combination with partial loops,such as a half loop, one and a half loops, two and a half loops or threeand a half loops, to name a few. The wire end at the far proximal end ofthe stabilizing end 16 may be terminated using a crimp, compressionsleeve, weld, glue joint or tether to connect it to the previous loop.By connecting the proximal loose end of the stabilizing end to theprevious loop, the hoop strength of the stability end is greatlyenhanced. This brings benefit in two ways. It reduces the likelinessthat the stabilizing end will be forced into a smaller diameter and bepulled into the airway. By preventing this, the odds of bringing longterm benefit for the patient are greatly increased. Also, there arecircumstances in which the treatment devices may need to be removed,such as times when the patient may have severe lung infection or lungcancer. In order to recapture and remove a device, large bronchoscopemust be utilized to provide a large bore channel and lumen for a forcepsor other instrument that will be used to connect to the treatmentdevice. These scopes typically provide a 2.0 mm channel and the scopeoutside diameter normally exceeds 6 mm. Large scopes such as the one weare describing cannot be guided past the 3rd generation airways so it isideal that the stabilizing end of the treatment device can be reliablyfixed at the ostium that joins 3rd generation airways. Most otherdevices that intend to treat these patients tend to migrate deeper inthe lung and they present the physician who is charged to remove themwith great difficulties.

In one embodiment, the shaft 12 forms the extendible midsection 18 alongthe longitudinal axis 19 and then bends radially outwardly distal to theextendible midsection 18, such as perpendicularly or at a 90 degreeangle to the longitudinal axis 19, forming a loop 70 in the same plane.Thus, the loop 70 has an opening 72 perpendicular to the longitudinalaxis 19 and has a circular shape. Likewise, in this embodiment, the loop70 extends nearly 360 degrees around the longitudinal axis 19.

The loops 70 may have any suitable diameter, typically in the range of10 mm to 12 mm, particularly when formed from a shaft 12 having adiameter of 0.3 mm. Thus, the overall diameter of the stabilizing end 16is typically smaller than the diameter of the tissue gathering end 14.When the stabilizing end 16 comprises a plurality of loops 70, each ofthe loops 70 may have the same diameter or differing diameters.Typically, the loops 70 are expandable so as to enlarge within an ostiumOS or other suitable portion of the tracheobronchial tree.

Typically, the stabilizing end 16 is the portion of the device 10 whichis pulled to re-tension the lung and locate the final placement of thedevice 10 for implantation. Therefore, in such embodiments, thestabilizing end 16 includes an attachment feature 38 to which thedeployment element 30 of the bronchoscope 20 is coupled. In theembodiment of FIG. 25 , the attachment feature 38 comprises a loop 40formed by the proximal tip of the shaft 12 of the device 10. Such aloop-shaped attachment feature 38 may be utilized with a compatibleattachment mechanism 36 on the deployment element 30, such as a tether42 and a support rod 44, as previously illustrated in FIGS. 8-9 . Thetether 42 extends through the loop 40 and around the support 42 so as tosecure the loop 40 to the support rod 44. Thus, the stabilizing end 16of the device 10 is able to remain attached to the deployment element 30during deployment by the attachment mechanism 36.

In other embodiments, the attachment feature 38 is located distally ofthe stabilizing end 16, such as illustrated in FIG. 26 . Here, theattachment feature 38 comprises a loop 40 formed by the shaft 12 betweenthe extendible midsection 18 and the stabilizing end 16. Again, such aloop-shaped attachment feature 38 may be utilized with a compatibleattachment mechanism 36 on the deployment element 30, such as a tether42 and a support rod 44, as previously illustrated in FIGS. 8-9 . Sincethe attachment feature 38 is distal to the stabilizing end 16, theattachment feature 38 may be pulled proximally in a way that allows thestabilizing end 16 to expand and anchor freely in the ostium. Thus, thestabilizing end 16 will be free to expand into the ostium OS whilepulling on the device 10 in the proximal direction during delivery.

It may be appreciated that other types of attachment features 38 may beused, such as threaded couplers, hook like wire forms, snap lockconnections etc.

In some embodiments, the shaft 12 has a separate proximal tip which is“turned-down” or facing in the proximal direction. In some embodiments,the proximal tip is aligned with the longitudinal axis 19 and in otherembodiments the proximal tip is offset from the longitudinal axis 19. Inany case, the turned-down configuration aligns the proximal tip 76 withor parallel with the direction of tension so as to avoid or reduce anytrauma to the surrounding tissue, such as blunt end agitation on theairway wall or bleeding or coughing that this brings. The proximal tip76 may have a variety of shapes including a coil, ball, end loop, coneshape or other blunt end shape that will minimize tissue agitationduring breathing related motion.

D. Shaft Materials

The pulmonary treatment device 10 may be formed from a single element,such as a continuous shaft 12, or from individual parts that are joinedtogether. When parts are joined together, they may ultimately appear asa continuous shaft 12, however the device 10 will include varioustransition zones where the parts are joined. In some embodiments, theparts are comprised of differing materials, etc. Thus, the shaft 12 willbe described herein and may refer to a single continuous shaft formingthe tissue gathering end 14, extendible midsection 18 and stabilizingend 16, or a shaft forming any one or more of these parts.

In some embodiments, the shaft 12 is comprised of a shape-memory alloy,such as nickel titanium (nitinol). Nitinol alloys exhibit two closelyrelated and unique properties: shape memory effect and super-elasticityor pseudo-elasticity. Shape memory is the ability of nitinol to undergodeformation at one temperature, then recover its original, undeformedshape upon heating above its “transformation temperature”.Super-elasticity occurs at a temperature range above its transformationtemperature; in this case, the transformation temperature should be setunder that of body temperature so no heating is necessary to cause theundeformed shape to recover, and the material exhibits enormouselasticity, some 10-30 times that of ordinary metal.

Thus, the desired configuration of the shaft 12 (e.g. bends, loops,etc.) is set during manufacturing of the device 10. The device 10 isthen able to be elongated, restrained, compressed or deformed, such thatwhen loaded within the delivery device, the pulmonary treatment devicerecovers to its original shape in free space. When the device 10 isdelivered to a confined space, the device 10 is able to recover towardits original shape, with modifications according to the confined space.Recovery force is tuned by adjusting Austenite final (A_(f)) temperatureusing heat treating of the alloy during manufacturing. An A_(f)temperature closer to body temperature (37° C.) lowers recovering force.An A_(f) temperature farther below body temperature increases recoveryforce. Thus, in some embodiments, an A_(f) temperature that is 5-50degrees below body temperature is preferred. In other embodiments, thepulmonary treatment device my beneficially be produced with a gradationof A_(f) temperatures. For instance, a large wire may be used to producethe device so the distal and proximal structures are strong, tuned withan A_(f) of 15 degrees C. to allow them to anchor into tissue reliablybut the extendable midsection, also constructed using the same largewire, may be thermally tuned so the A_(f) is 30 degrees C. (closer to 37degrees C., typical body temperature) so the extendable midsection isweaker and the spring stress versus strain ratio is lower. Any number ofA_(f) temperatures may be set at any location on the implant in order toenhance performance.

In some embodiments, the metallic surface of the nitinol is stripped ofcontaminants and oxides to native metal. The nitinol is then passivatedto form a thin layer of titanium dioxide on the surface for optimalbiocompatibility. In some embodiments, the thin layer is 0.5-10 μmthick, preferably 2 μm thick.

In some embodiments, the shaft 12 is comprised of a metal, such asstainless steel, steel containing chromium, steel containing cobalt,steel containing chrome, a metal alloy with nickel and/or titanium, abiocompatible metal that is fully elastic after being strained, or acombination of these, to name a few. In some embodiments, the metallicsurface of the metal is stripped of contaminants and oxides to nativemetal. The metal is then passivated to form a thin layer of chromiumoxide (when the metal is steel-based) on the surface for optimalbiocompatibility. In some embodiments, the thin layer is 0.5-10 μmthick, preferably 2 μm thick.

In some embodiments, the shaft 12 is comprised of other materials, suchas composites (e.g. carbon fiber) or ceramics, polymers, polyimide film(e.g. Kapton®), para-aramid synthetic fiber (e.g. Kevlar®), nylons,polyimides, metals such as titanium, nickel alloys, nitinol, memoryshape alloys such as martensite nitinol or super-elastic forms ofnitinol.

In some embodiments, the shaft 12 is comprised of wire, such asround-section wire, or square or rectangular section ribbon. The shaft12 may be solid or hollow, such as comprised of tubing. All edges of theshaft 12 are free of sharp edges to minimize inflammation and therelated granulation tissue that is formed from cyclic agitation of thesoft tissues in the lung.

In some embodiments, the shaft 12 has a diameter between 0.010inches-0.080 inches, but preferably between 0.009 and 0.023 inches.

E. Shaft Tips

As mentioned, the shaft 12 has a distal tip 54 and a proximal tip 76. Insome embodiments, such tips 54, 76 are optimized to assist inadvancement of the device 10 from the delivery device. Typically, thetips 54, 76 have a blunt surface to reduce any potential injury orinflammation of tissue due to delivery. In addition, in someembodiments, the tips 54, 76 include a feature which assists inresisting relative motion between the tips 54, 76 and the surroundingtissue. This helps to resist sliding or movement of the tips 54, 76towards the center of the implant, such as toward the extendiblemidsection 18. Such resistance to tip migration bolsters storage ofpotential energy in the device 10 rather than losing energy duringmigration. Thus, for example, the distal tip 54 can advance but resistsmoving backwards, in the proximal direction, and the proximal tip 76 canbe pulled proximally but resists moving in the distal direction.

FIGS. 27A-27D illustrate example tips 90 suitable for either the distaltip 54 or proximal tip 76. Each of the tips 90 are formed at the end ofthe shaft 12. FIGS. 28A-28B illustrate example methods of forming suchtips 90. To begin, FIG. 27A illustrates an embodiment of a tip 90 havinga ball shape. Such a ball shape may be formed by melting the distal-mostportion 92 of the shaft 12, as illustrated in FIG. 28A. Here, a formingtool, such as a copper mold 96 is positioned a distance d from the endof the shaft 12. The copper mold 96 serves as a heat sink. Thedistal-most portion 92 of the shaft 12 is then melted while the coppermold 96 stops the melt-back, forming the ball. Thus, the length ofdistance d determines the size of the ball shaped tip 90.

FIG. 27B illustrates an embodiment of a tip 90 having a cylindricalshape. Such a cylindrical shape may be formed by melting the distal-mostportion 92 of the shaft 12, as illustrated in FIG. 28B. Here, a formingtool, such as a copper casting tool 98 or welding arc, is positioned adistance d from the end of the shaft 12. The copper casting tool 98serves as a heat sink and a mold. The distal-most portion 92 of theshaft 12 is then melted into the casting tool 98 forming a cylindricalshape. Again, the length of distance d determines the size of thecylindrical shaped tip 90.

FIG. 27C illustrates an embodiment of a tip 90 having a blunt large boreshape. A tube is placed over wire and the wire and tube are weldedtogether, to yield a hemisphere tip and tube with a chamfer or straightcut back edge to grab tissue.

FIG. 27D illustrates an embodiment of a tip 90 having a coil spring andspherical end shape. By placing a coil over the wire, positioning thecoil end coincident with the wire end and striking a welding arch at theend, a hemispherical weldment is created that joins the coil and wirethat is blunt and larger diameter than the bare wire would be withoutthe benefit of the coil. The wire coil or tube used to make the tips canbe made from titanium, nitinol or a more radiopaque material such astungsten, tantalum, gold or platinum.

In each of these embodiments, the tip 90 is smooth to allow removal ofthe device 10 if desired, but the increase in diameter compared to theshaft 12 allows the tip 90 to catch on a portion of tissue, particularlyin an area of damaged tissue DT, which assists in anchoring the tip theplace.

It may be appreciated that in some embodiments, the tip 90 functions asan attachment feature 38. In such embodiments, the tip 90 includes ahole or opening 120, as illustrated in FIGS. 29A-29D, which is used toconnect with an attachment mechanism 36. Thus, a tether 42 can be passedthrough the opening 120 and around a support rod 44, so as to secure thetip 90 to the support rod 44. This allows the device 10 to be attachedto the deployment element during delivery, as described previously.

F. Jacket

In some embodiments, the pulmonary treatment device 10 includes one ormore jackets 80. A jacket 80 is a covering that extends over the shaft12, such as to increase the diameter of the shaft 12, increaseengagement quality with surrounding tissue, increase surface area of theshaft 12, and/or to provide drug delivery, to name a few. The jacket 80may be formed from a variety of materials, such as metals (e.g.stainless steel, titanium, nitinol, nickel, cobalt chrome, or acombination of these) or polymers (e.g. polycarbonate urethane,polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP),polyimide film (e.g. Kapton®), polyimide, polyether ether ketone (PEEK),polyethylene, ethylene-vinyl acetate (EVA) (also known as poly(ethylene-vinyl acetate) (PEVA)), polypropylene, polyvinyl alcohol(PVA), polyurethane, nylon, polyether block amides (PEBA), acrylonitrilebutadiene styrene (ABS), polybutyrate, polyethylene terephthalate (PET),polysulfone (PES), ethylene tetrafluoroethylene (ETFE), polyvinylidenefluoride (PVDF), thermoplastic polyurethane elastomers (e.g.Pellethane®), aliphatic polyether-based thermoplastic polyurethanes(TPUs) (e.g. Tecoflex®), or a combination of these). Likewise, thejacket 80 may be formed from a metallocene. A metallocene is a compoundtypically comprising two cyclopentadienyl anions (Cp, which is C₅H⁻ ₅)bound to a metal center (M) in the oxidation state II, with theresulting general formula (C₅H₅)₂M.

The jacket 80 may take a variety of forms. In some embodiments, thejacket 80 comprises a wire, extrusion or sleeve that is welded to,over-molded, shrunk to, glued to, adhered to, compression fit to orotherwise joined with the shaft 12. In some embodiments, the jacket 80has the form of a coil which is advanced over the shaft 12 in thedesired area. In such embodiments, a ball or other feature may be weldedto the shaft 12 to hold the jacket 80 on the shaft 12. In otherembodiments, the jacket 80 comprises a coating.

Both FIG. 25 and FIG. 26 illustrate a pulmonary treatment device 10having a plurality of jackets 80. For example, the device 10 includes afirst jacket 80 a positioned over the tissue gathering end 14. In someembodiments, the first jacket 80 a covers the entire tissue gatheringend 14, as shown, and in other embodiments, the first jacket 80 a coversa portion of the tissue gathering end 14. An example of such a firstjacket 80 a is a 2.0 mm diameter nitinol coil; such a jacket may besuitable for positioning over, for example, a shaft 12 comprising a 1.0mm diameter wire. This allows passage of the tissue gathering end 14through a 2.0 mm channel of a bronchoscope 20. However, it may beappreciated that other sized jackets may be used, particularly in therange of 0.5-3.0 mm diameter. For example, if a therapeutic scope isused as a delivery device (having a 2.8 mm channel), a jacket having a2.8 mm diameter may be used. Increasing the cross sectional area of thetissue gathering end increases the bearing area imparted on the tissuewhich reduces the pressure imparted on the tissue and this reducesimplant migration or implant ingrowth through the tissue. These benefitsare important as they increase the durability of the treatment.

In FIG. 25 and FIG. 26 , the device 10 includes also includes a secondjacket 80 b positioned over the stabilizing end 16. In some embodiments,the second jacket 80 b covers the entire stabilizing end 16 (FIG. 25 ),and in other embodiments, the second jacket 80 b covers a portion of thestabilizing end 16 (FIG. 26 ). An example of such a second jacket 80 bis a 0.50-4 mm diameter nitinol coil but most preferably a 2.5-2.8 mmdiameter coil; such a jacket may be suitable for positioning over, forexample, a shaft 12 comprising a 0.2-0.3 mm diameter wire. This alsoallows passage of the stabilizing end 16 through a 2.8 mm channel of abronchoscope 20. Again, it may be appreciated that other sized jacketsmay be used, particularly in the range of 0.5-4.0 mm diameter. Forexample, if a therapeutic scope is used as a delivery device (having a2.8 mm channel), a jacket having a 2.8 mm diameter may be used.

The second jacket 80 b increases the area that is engaging tissue. Bymaximizing the bearing area in contact with the tissue to be greaterthan 9.81E-8 square inches but preferably more than 10E-7 square inchesof bearing area per linear inch along the implantable device centroid+,the potential for device migration through tissue is nearly eliminated.This reduces erosion into the airway by the device 10 to increasetreatment effect durability. In addition, the second jacket 80 bprevents the stabilizing end 16 from “cheese wiring” or cutting throughthe soft ostium tissue.

In some embodiments, the jacket 80 provides controlled delivery of anagent, such as a drug. In some instances, such delivery reduces the rateof wound healing, tissue remodeling, inflammation, generation ofgranular tissue, and hyperplasia, to name a few.

Alternative Embodiments

It may be appreciated that the pulmonary treatment device 10 may take avariety of alternative forms. In such embodiments, the device 10 mayinclude elements similar in function but differing in form. Or, theembodiments may include features which function differently but stillsatisfactorily treat the lung. FIG. 30 illustrates an embodiment of adevice 10 configured from a shaft 12 comprising a hollow tube. In thisembodiment, the device 10 includes a tissue engaging end 14, anextendible midsection 18, and a stabilizing end 16, each laser cut fromthe hollow tube. Here, the tissue engaging end 14 includes one or morewings 100 which extend radially outwardly from the longitudinal axis 19when deployed. Each wing 100 has an elongate shape formed from the shaft12, such as by laser cutting longitudinal slits in the shaft 12 from theextendible midsection 18 to the distal tip 54. Thus, the tissue engagingend 14 is configured to have a slim profile, wherein the wings 100extend in parallel to the longitudinal axis 19, while the tissueengaging end 14 is disposed within the delivery device. Each wing 100also has a predetermined bend location 102, typically midway along thelength of the wing 100. Upon deployment, each wing 100 juts radiallyoutwardly, perpendicular to the longitudinal axis 19, by bending at itsbend location 102. This creates an expanded profile which allows the end14 to engage the damaged tissue DT of the lung. As each wing 100 bendsradially outwardly, the expandable midsection 18 and distal tip 54 aredrawn toward each other.

In this embodiment, the extendible midsection 18 is also laser cut fromthe hollow tube shaft 12. Here, the hollow tube is cut in a helical orspiral shape to form a spring or coil. Further, in this embodiment, thestabilizing end 16 is also cut from the hollow tube shaft 12. Here, thestabilizing end 16 includes at least one prong 104 cut from the shaft12. Each prong 104 may have any suitable shape but is typically elongatehaving a free end with an atraumatic tip 106. The stabilizing end 16 isconfigured to have a slim profile, wherein the prongs 104 extend inparallel to the longitudinal axis 19, while the stabilizing end 16 isdisposed within the delivery device. Each prong 104 also has apre-curvature which causes the prong 104 to bend radially outwardly,away from the longitudinal axis, upon deployment. This allows thestabilizing end 16 to expand in a desired lung area, such as an ostium,to stabilize the position of the device 10 when implanted. In thisembodiment, the stabilizing end 16 also includes an attachment feature38 for attaching to an attachment mechanism 36 on the deployment element30 during deployment. In this embodiment, the attachment feature 38comprises a hole cut into the tubular shaft 12.

Delivery Device Embodiments

As mentioned previously, the pulmonary treatment device 10 is sized andconfigured to be delivered by a delivery device that is insertable intothe lung, such as a steerable scope (e.g. bronchoscope 20), catheter orother delivery system. The delivery device is configured to be advancedwithin any anatomical lumen in the lung that is either innate or createdwithin the lung, either by disease or with the use of an instrument. Anexample delivery device is a bronchoscope 20, an embodiment of which isillustrated in FIG. 31A-31B. In this example, the bronchoscope 20includes a bronchoscope body 200 and an insertion cord 202. Theinsertion cord 202 is advanced into the endobronchial tree of thepatient and the bronchoscope body 200 remains outside of the patient,typically grasped by the operator's non-dominant hand. The insertioncord 202 contains a fiberoptic bundle for light and image transmission,tip bending control wires and a working channel. The average length ofthe insertion cord 202 is 600 mm (range 500-650 mm). The working channelcontinues into the bronchoscope body 200, exiting at the working channelport 204. The bronchoscope body 200 also includes an eye piece (whichcan be attached to a camera for display on a screen-fiberoptic scopeshave an eye piece; video scopes do not), diopter ring (for focusing),and control lever. The control lever is used to control the distal tipof the insertion cord 202. Typically, the control lever is used to movethe insertion cord tip 208 up/down and/or side-to-side, whereas rotationis typically achieved by rotation of the bronchoscope body 200 with theoperator's wrist and shoulder. The bronchoscope 20 also includes a lightsource which can be supplied via a cable 206 or a portable batterypowered source. The light source may be halogen, incandescent or LED, toname a few. FIG. 31B illustrates an end view of the insertion cord tip208. As shown, the working channel 210 extends through the tip 208,allowing delivery of the pulmonary treatment device 10 therefrom.

As mentioned previously, in some embodiments, the pulmonary treatmentdevice 10 is configured to be delivered through a lumen in the deliverydevice, such as by pushing the treatment device through a lumen of ascope, catheter, introducer, sheath, sleeve or similar device. Forexample, in some embodiments, the pulmonary treatment device 10 isloaded directly into the working channel port 204 and advanced throughthe working channel 210 for delivery from the insertion cord tip 208.

However, in other embodiments, the device 10 is pre-loaded into anintroducer which is advanceable into the working channel 210 fordelivery therefrom. In other embodiments, the treatment device 10 ismounted on a guidewire which constrains portions of the device 10,preventing these portions from expanding radially. The device 10 andguidewire are advanced together into the working channel 210 fordelivery therefrom. In another embodiment, the device is pre-loaded onthe guidewire which is advanceable into the working channel 210 fordelivery therefrom.

FIG. 32 illustrates an embodiment of an introducer 220 having apre-loaded pulmonary treatment device 10. In this embodiment, theintroducer 220 comprises an elongate tube 222 having a first end 224 anda second end 226. The elongate tube 222 is comprised of any suitablematerial, such as metal, stainless steel, polymer or composite tubing.Typically, the elongate tube 222 has a bend to assist in insertion intothe working channel port 204 or is bendable to both assist in insertionand to allow for compact packaging (such as positioning into round trackor square track packaging without kinking). In any case, the introducer220 should be strong enough to keep the device 10 from distorting from astraight configuration and hard enough that the device 10 cannot indentinto the wall of the introducer 220, particularly during thesterilization process that involves heating to 130-180° C. Theintroducer 220 can be any suitable length, such as a minimum of 2 incheslonger than the device 10 therein and a maximum of half the length ofthe deployment element 30. In some embodiments, the introducer 220 has alength of 4 to 20 inches, preferably 10 inches.

FIG. 32 illustrates the stabilizing end 16 and the extendible midsection18 loaded within the introducer 220. Here, the tissue gathering end 14is disposed outside of the introducer 220 and allowed to coil into itsexpanded state. In some embodiments, the tissue gathering end 14 ispackaged in this configuration to reduce stress on the end 14 duringtransport and sterilization. In such embodiments, the tissue gatheringend 14 is then retracted into the introducer 220 prior to use. In thisembodiment, the first end 224 of the introducer 220 is removably joinedwith a funnel 230 to assist in retracting the tissue gathering end 14into the introducer 220. Thus, the funnel 230 has a tapered shape whichgradually draws the tissue gathering end 14 radially inward toward theinterior lumen of the introducer 220. Once the tissue gathering end 14resides within the introducer 220, the funnel 230 is removed.

In this embodiment, the device 10 is attached to a deployment element 30by tether 42. The deployment element 30 comprises an elongate shaft 32,typically having an interior lumen extending therethrough. The elongateshaft 32 may take various forms, including a coiled shape, as shown andmay be comprised of a variety of materials, such as metal or polymer. Insome embodiments, the shaft 32 is comprised of a wire or polymer coilhaving a flexible exterior sheath or liner that minimizes kinking as itis advanced through the working channel 210 of the bronchoscope 20.Likewise, in some embodiments, the shaft 32 includes an interior liner,such as of polytetrafluoroethylene or other polymer, to protect thetether 42 passing therethrough from breaking. In other embodiments shaft32 is comprised of a braided frame with a liner (such as comprised ofpolytetrafluoroethylene) and an outer jacket (such as comprised ofthermoplastic elastomer or flexible polyamide). It may be appreciatedthat in some embodiments, the elongate shaft 32 has a solid centerrather than a hollow center. It may also be appreciated that thedeployment element 30 may have any suitable length, such as 13-45inches, preferably 34 inches.

When the elongate shaft 32 is hollow or has an interior lumen, thetether 42 passes through the interior lumen, through the attachmentfeature 38 and then back through the interior lumen of the deploymentelement 30 creating two free ends 240 of the tether 42. The tether 42may be comprised of any suitable material such as a monofilament orbraided high strength polymer, a carbon fiber, or a thread or braidcomprising metal, stainless steel, nitinol, titanium, steel alloyed withchrome or cobalt, polytetrafluoroethylene, and/or material from a familyof ultra-high molecular weight polymers, to name a few.

In this embodiment, the deployment element 30 extends out of the secondend 226 of the introducer 220 and culminates in a hub 242 which holdsthe free ends 240 of the tether 42. Thus, the device 10 is able toremain attached to the deployment element 30 by tether 42 duringdeployment. In this embodiment, the hub 242 of the deployment element 30comprises a base 244 and a top 246. Here, each of the base 244 and top246 are thumb knob shaped for ease of use. In this embodiment, the base244 is crimped, glued or welded to the shaft 32 of the deploymentelement 30. The free ends 240 of the tether 42 extend from the shaft 32and then pass through the base 244, typically within a cavity 248therein. Such passage through the cavity 248 ensures that the tether 42is not abraded by the base 244. In this embodiment, the cavity 248 hastapered walls leading to the shaft 32 so as to minimize the size of thecavity 248 while ensuring adequate space for the tether 42. The freeends 240 then pass through the top 246 where they are separated intoindividual lumens 230. The lumens 230 are spaced apart to impart amoment while twisting to make length reduction related tightening moreeffective. In this embodiment, the free ends 240 then wrap around asupport 250 which reduces stress on the tether 42. Typically, thesupport 250 has an atraumatic shape, such as a cylinder or ball. Thefree ends 240 are then held together with a clip 252.

FIG. 33 illustrates another embodiment of an introducer 220 having apre-loaded pulmonary treatment device 10. In this embodiment, theintroducer 220 again comprises an elongate tube 222 having a first end224 and a second end 226. The elongate tube 222 is comprised of anysuitable material, such as metal or polymer. In this embodiment, thedevice 10 comprises a tissue gathering end 14 and a stabilizing end 16,without an extendible midsection 18. FIG. 33 illustrates the tissuegathering end 14 and stabilizing end 16 loaded within the introducer220.

In this embodiment, the deployment element 30 is attached to theattachment feature 38 of the device 10 by tether 42. The deploymentelement comprises an elongate shaft 32 having an interior lumenextending therethrough. The elongate shaft 32 may take various forms,including a coiled shape, as shown. The tether 42 passes through theinterior lumen of the deployment element 30, through the attachmentfeature 38 and then back through the interior lumen of the deploymentelement 30 creating two free ends 240 of the tether 42. In thisembodiment, the deployment element 30 extends out of the second end 226of the introducer 220 and culminates in a hub 242 which holds the freeends 240 of the tether 42. Thus, the device 10 is able to remainattached to the deployment element 30 by tether 42 during deployment. Inthis embodiment, the hub 242 of the deployment element 30 comprises abase 244. In this embodiment, the base 244 is crimped, glued or weldedto the shaft 32 of the deployment element 30. In this embodiment, thefree ends 240 then wrap around a support 250 which reduces stress on thetether 42. Typically, the support 250 has an atraumatic shape, such as acylinder or ball. The free ends 240 are then held together with a clip252.

In any case, the use of a pre-loaded introducer 220 allows for ease inloading of the bronchoscope 20 for delivery of the device 10therethrough. The introducer 220 holds the device 20 in a relativelystraight configuration so it can easily be introduced into thebronchoscope 20. In some embodiments, the introducer 220 also holds thedevice 20 in a radially compressed configuration so that it can beadvanced through the working channel 210 of a bronchoscope 20 having aconventional inner diameter (e.g. 2.0 mm). Thus, the operator isrelieved from any manipulation of the device 10 during loading of thebronchoscope 20 and is ensured proper orientation and delivery.

As illustrated in FIG. 34 , the pre-loaded introducer 220 is advanceableinto the working channel port 204 of the bronchoscope 20, typically oncethe bronchoscope 20 has been desirably positioned within the lung. Insome embodiments, the introducer 220 has a shape, such as a male luertaper, that sockets into the working channel port 204. Such advancementinto the port 204 relieves the operator from holding the device 10during delivery. As shown, the device 10 is advanced from the first end224 of the introducer 220 and into the working channel 210 byadvancement of the deployment element 30. Thus, the deployment element30 pushes the device 10 through the introducer 220 and through theworking channel 210 of the bronchoscope 20.

FIG. 35 illustrates the insertion cord tip 208 of the bronchoscope 20positioned in the damaged tissue DT of the patient's lung. The positionof the insertion cord tip 208 indicates the delivery location of thetissue gathering end 14. The tissue gathering end 14 is deployed at thisdelivery location by retraction of the bronchoscope 20 while holding thedeployment element 30 fixed. Thus, the deployment element 30 andattached device 10 remain fixed in relation to the anatomy while thebronchoscope 20 is retracted. This exposes the tissue gathering end 14,allowing the tissue gathering end 14 to expand into a deployedconfiguration. In this embodiment, the tissue gathering end 14 comprisesa loop 50 deployed in a plane perpendicular to the longitudinal axis 19of the device 10.

Once the tissue gathering end 14 is deployed, the lung is ready forre-tensioning. This can be achieved by a variety of methods. In oneembodiment, the deployment element 30 is fixed relative to thebronchoscope 20 and together the deployment element 30 and bronchoscope20 are retracted. Such retraction pulls the tissue gathering end 14toward the larger bronchioles and trachea, which in turn pulls thedamaged tissue DT, because the device 10 is connected to the deploymentelement 30. This is continued until a desired level of re-tensioning ofthe lung, has been achieved. It may be appreciated that the deploymentelement 30 and bronchoscope 20 can be advanced and retracted together asneeded to adjust the level of re-tensioning, if desired.

As mentioned, other methods of delivery and re-tensioning can beachieved with the pulmonary treatment device 10. In some embodiments,the tissue gathering end 14, optional midsection 18, and stabilizing end16 are all deployed prior to the re-tensioning step. Thus, once thedevice 10 has been deployed, re-tensioning can be achieved by retractingthe deployment element 30 and bronchoscope 20 together as describedpreviously. The retraction pulls the device 10 toward the largerbronchioles and trachea, which in turn pulls the damaged tissue DT.Retraction continues until the stabilizing end 16 is seated in a desiredportion of the airway. Once the operator is satisfied with the placementof the device 10, the device 10 is detached from the deployment element30.

It may be appreciated that the device 10 may alternatively be deployedfrom the bronchoscope 20 by advancing the deployment element 30, therebypushing the device 10 out of the working channel 210 of the bronchoscope20. In such embodiments, the deployment element 30 typically has a lowcompressibility. Such deployment of the device 10 can be achieved all atonce or in separate steps. Since the deployment element 30 is attachedto the device 10, re-tensioning can be achieved by the same methods asdescribed above (i.e. retraction of the deployment element 30 andbronchoscope 20). Once the operator is satisfied with the placement ofthe device 10, the device 10 is detached from the deployment element 30.

It may be appreciated that in some embodiments, the device 10 isdelivered to the desired location within the lung with the use of aguidewire and/or catheter, passed through the working channel 210 of abronchoscope 20 or alone.

When more than one device 10 is to be implanted into the patient duringa procedure with the use of a bronchoscope 20, the bronchoscope 20 istypically exchanged or cleaned before implanting the next device 10.Since bronchoscopes 20 typically not disposable, they are designed forsuch cleaning protocols. The ability to easily exchange or clean thedelivery device between uses reduces any risk of cross-contaminationfrom one portion of the lung to another and/or from one lung to another.Previously, when using conventional devices and treatment protocols,both lungs of a patient could not be treated during the same proceduredue to risks of cross contamination between both lungs which could provefatal to the patient. However, the delivery methods and devices of thepresent invention reduce or eliminate this risk.

It may be appreciated that an additional device 10′ can be implantedinto the same airway as a previous implanted device 10. In someembodiments, the additional device 10′ is passed through the previouslyimplanted device 10 to reach a more distally located area of the lung.

In some embodiments, the device 10, attached deployment element 30 andintroducer 220 are packaged or pouched as a single unit. Each unit isused to treat a particular target location in the lung. In someembodiments, the units are sold individually since the number of devices10 implanted in a single lung will vary depending on the patient'sdisease state and a variety of other features. In other embodiments, theunits are sold by the box wherein each box contains a plurality ofunits. In some embodiments, 6-14 devices are delivered to a single lungduring a treatment session. If two lungs are treated during a singletreatment session, upwards of 30 devices may be used. It may beappreciated that in some embodiments, the procedure has a flat costwherein an unlimited number of devices 10 may be used during theprocedure for the same cost. This allows the operator to focus on thetechnical aspects of the procedure rather than on the cost of usingadditional units.

It may be appreciated that in some embodiments, two or more devices 10are joined or fixed together within the lung anatomy. FIGS. 36-37illustrate an embodiment wherein two devices 10 are joined with the useof a joining device 300. FIG. 36 illustrates a first device 10 aimplanted at a first location within a lung L and a second device 10 bimplanted at a second location within lung L. In this embodiment, thefirst and second locations are along lung passageways branching from thesame ostium OS. As shown, the tissue gathering ends 14 are disposed indamaged tissue DT and the stabilizing ends 16 are located more proximalalong the respective lung passageways. In addition, each device 10 a, 10b has a respective tether 42 a, 42 b attached to its attachment feature38. The tethers 42 a, 42 b extend from the devices 10 a, 10 b to theexterior of the patient. The delivery device is not shown in FIG. 36 forclarity, however the tethers 42 a, 42 b extend through the deliverydevice to the exterior of the patient. The joining device 300 is thenadvanced over the free ends 240 a, 240 b of the tethers 42 a, 42 b. Inthis embodiment, the joining device 300 comprises a clip having a firstarm 302 a and a second arm 302 b, wherein the arms 302 a, 302 b areconnected by a connector 304. Each arm 302 a, 302 b has a respectivelumen 306 a, 306 b through which an individual tether passes. Thus,joining device 300 is advanced over the free ends 240 a, 240 b so thatthe first tether 42 a passes through the lumen 306 a of the first arm302 a and the second tether 42 b passes through the lumen 306 b of thesecond arm 302 b. The joining element 300 is then advanced along thetethers 42 a, 42 b until the arms 302 a, 302 b reach the devices 10 a,10 b. As illustrated in FIG. 37 , the joining device 300 is thenadvanced so as to attach the first arm 240 a to the first device 10 andthe second arm 240 b to the second device 10 b. In this embodiment, thejoining device 300 resides within the ostium OS, each arm 302 a, 302 bextending toward a separate lung passageway, thereby creating a V or Ushape. The tethers 42 a, 42 b are removed and the joining device 300 isleft in place.

It may be appreciated that in some embodiments, the clip having thefirst arm 302 a and the second arm 302 b is configured to applycompression force to tissue between the arms 302 a, 302 b when tissue isinserted therebetween. For example, in some embodiments, the arms 302 a,302 b are configured to be advanced a sufficient distance within theseparate lung passageways of the bifurcation so as to apply force to theinner walls of the lung passageways. Such force pushes the lungpassageways toward each other, straightening the passageways whilecompressing the tissue therebetween.

In other embodiments of the invention, the pulmonary treatment device 10is mounted on the outside of the bronchoscope 20. Mounting the device 10on the outside of the bronchoscope 20 avoids packing the device 10within a bronchoscope working channel 210 or catheter within abronchoscope channel which involves restraining the device 10 in a highstrain configuration. Once restrained, the device 10 would thentransition to a more relaxed configuration upon deployment. However, bymounting the device 10 on the outside of the bronchoscope 20, device 10can be delivered into the patient in a non-stressed and non-strainedstate. This configuration provides the benefit of reliably deliveringthe treatment device 10 along the delivery path in substantially thesame shape as it will be when it is inserted into the target airway. Inaddition, the device 10 may be comprised of a broader selection ofmaterials, including high strength materials that would typically beunsuitable for such restraint and relaxation. In some embodiments, thetreatment device 10 may be comprised of titanium, steel, astainless-steel alloy, one or more ferrous metals, one or morenon-ferrous metals, metals that contain nickel, iron, and/or manganese,or any combination of these listed materials. In other embodiments, thetreatment device 10 may also be comprised of a polymer material, aceramic material or a composite material that is made from anycombination of plastic, metal, carbon, carbon fiber or any othermaterial that exhibits resilience and biocompatibility performance, suchas nitinol or an alloy made from nickel and titanium. It may beappreciated that, in some embodiments, materials that can perform in afully reversible elastic way up to a minimum of 1% strain are verysuitable.

FIG. 38 illustrates an embodiment of a delivery system 301 fordelivering a treatment device 10. In this embodiment, the system 301includes a bronchoscope 20 having a bronchoscope body 200 and aninsertion cord 202 with an insertion cord tip 208. Suitable bronchoscopeouter diameters may be as large as 10 mm in diameter but they may alsobe as small as 1 mm diameter. More typically, the bronchoscope isbetween 2 mm and 3 mm outer diameter. In this embodiment, the deliverysystem 301 further includes a deployment sleeve 311 and a guidewire 313,both of which may be utilized in delivering particular embodiments ofthe treatment device 10. As shown, the deployment sleeve 311 includes aproximal end 310 and a distal end 312. The deployment sleeve 311 isadvanceable through the working channel 210 of the bronchoscope 20, suchas extending through the working channel port 204 and beyond theinsertion cord tip 208, as shown. In some embodiments, the deploymentsleeve 311 is comprised of a polymer tube, a polymer or metallic roundwire coil, a ribbon coil, a braid reinforced sleeve, an extrusion or anycombination of these. In some embodiments, the deployment sleeve 311 hasan outer diameter of up to 5 mm but preferably its outer diameter isbetween 2 mm and 4 mm with an inside diameter as small as 0.010″, butmore preferably it has an inside diameter of 0.018-0.040 inches.Additionally, in some embodiments, a guidewire 313 is advanceablethrough the deployment sleeve 311, as illustrated in FIG. 38 . In someembodiments, the guidewire 313 is comprised of a stainless steel ornitinol core wire with a stainless-steel or nitinol wound coil outerjacket. The guidewire diameter may be as small as 0.010″ and as large as3 mm, ideally but it's ideally between 0.025-0.040 inches in diameter.In some embodiments, the guidewire 313 and deployment sleeve 311 arelonger than 60 cm, preferably 90 to 110 cm. Other embodiments include amuch longer guidewire that is 90 cm to 250 cm long, with sufficientlength so that pulmonary treatment devices may be removed from thepatient or exchanged on and off of the guidewire with enough excessguidewire length to allow the maneuvers to be accomplished without everneeding to let go of the guidewire. This insures that the guidewirestays in an appropriate position while exchanges are being made FIG. 39illustrates an embodiment of a pulmonary treatment device 10 that isdeliverable by the system 301 of FIG. 38 . In this embodiment, thepulmonary treatment device 10 comprises a tissue gathering end 14, anextendible midsection 18 and a stabilizing end 16. In this embodiment,the stabilizing end 16 comprises a coil having a flared configuration,as illustrated in FIG. 39 . Here, the outer diameter of the stabilizingend 16 generally matches that of the extendible midsection 18 and thengradually expands moving away from the midsection 18 forming the flaredconfiguration. The flared configuration can assist in seating thestabilizing end 16 within the airway, particularly within an ostium. Inthis embodiment, the stabilizing end 16 also includes a connector 326which assists in maintaining the shape of the stabilizing end 16. Whenthe stabilizing end 16 is comprised of a coil, the free end of the coilis connected with the remainder of the coil by the connector 326 toensure that the free end does not cause trauma to tissue, such as duringdelivery and deployment. Such connection of the free end to theremainder of the coil forms a complete hoop which increases the hoopstrength of the most proximal portion of the stabilizing end 16. In someinstances, the increased hoop strength assists in anchoring thestabilizing end 16 in a portion of the lung airway.

In this embodiment, the extendible midsection 18 also comprises a coil,however the midsection 18 typically has a uniform diameter. The diameteris typically chosen so as to be mountable on a bronchoscope 20 or otherdelivery device, such as a guidewire. The extendible midsection 18 isable to be elongated to store elastic strain energy which urges thetreatment device 10 to recover back to a non-elongated length.

In this embodiment, the tissue gathering end 14 comprises an anchorstrut 322 which is extendable radially outwardly from the longitudinalaxis 19 to assist in anchoring the device 10 within a lung passageway orwithin damaged tissue. Anchor strut 322 may extend 1 mm to more than 30mm but 6-12 mm is preferable. The anchor strut 322 terminates in ananchor strut end 321, which may have a variety of shapes including acoil, ball, sharp end barb, L shaped pad, strain relief long coil ortapered coil. The anchor strut 322 is configured to extend radiallyoutwardly upon deployment so at least the anchor strut end 321 engagesan airway wall W or damaged tissue DT, such as in the area of thealveolar sacs. However, in some instances, the anchor strut 322 itselfadditionally engages the airway wall W or damaged tissue DT.

During delivery and prior to deployment, the anchor strut 322 is held ina retracted or un-extended position so as to avoid dragging along theairway walls W or traumatizing tissue. Such retraction is maintained byan alignment element 320. In this embodiment, the alignment element 320has the form of a loop, however it may be appreciated that the element320 may have the form of a partial loop or snap locking structure,partial loop, hook shaped lock or spring lock mechanism. When the centerof the loop is aligned with the longitudinal axis 19, the anchor strut322 is held parallel to or at a small angle in relation to thelongitudinal axis 19. Such alignment may be maintained by passing adevice, such as the bronchoscope 20 or guidewire, catheter, ballooncatheter, hitch lock wire, or other accessories related thereto, throughthe center of the treatment device 10 and through the alignment element320 (as will be illustrated in later sections). The tissue gathering end14 is configured so as to bias the alignment element 320 and attachedanchor strut 322 radially outwardly. Therefore, withdrawal of devicesfrom the alignment element 320 frees the alignment element 320 andallows the alignment element 320 to rotate away from alignment with thelongitudinal axis 19. This, in turn, causes the anchor strut 322 toextend radially outwardly, as illustrated in FIG. 39 . Thus, in theextended position, the alignment element 320 has an axis 19 which is atan angle θ to the longitudinal axis 19. Typically, the angle θ is in therange of 1 to 90 degrees but it's preferably 20-65 degrees. In someembodiments, additional portions of the tissue gathering end 14 are alsobiased to assist in extension of the anchor strut 322 radiallyoutwardly. For example, in some embodiments, the tissue gathering end 14includes a body strut 323 which is connected to the anchor strut 322. Insuch embodiments, the body strut 323 is biased so as to further extendthe anchor strut 322 radially outwardly. In the embodiment of FIG. 39 ,the body strut 323 is disposed opposite the anchor strut 322 so that thealignment element 320 is disposed therebetween. Thus, when the center ofthe alignment element 320 is aligned with the longitudinal axis 19, thebody strut 323 and anchor strut 322 reside on opposite sides of thelongitudinal axis 19. In some instances, release of the alignmentelement 320 allows both the body strut 323 and anchor strut 322 to biastoward their relaxed configurations (such as pushing both the body strut323 and anchor strut 322 outwardly in the same radial direction). Thiscan allow the body strut 323 and anchor strut 322 to spread fullyelastically at least 5 degrees but up to 90 degrees, and preferably 20to 65 degrees, to push the anchor strut end 321 into or through the wallof an airway or the diseased tissue to anchor the tissue gathering end14 in the lung tissue.

In some embodiments, the tissue gathering end 14 further includes aguide element 319, such as illustrated in FIG. 39 . In this embodiment,the guide element 319 comprises a coil, however the element 319 may haveany suitable shape including a single loop. In some embodiments, theguide element 319 helps keep the device 10 centered on the end of thebronchoscope 20 or other delivery device such as a guidewire, catheteror balloon catheter. In some embodiments, the guide element 319 isarranged so that a guidewire emerging from the insertion cord tip 208 ofthe bronchoscope 20 passes through the guide element 319. This assistsin aligning the tissue gathering end 14 with the longitudinal axis 19and holding the body strut 323 and anchor strut 322 in its retractedposition during delivery, prior to deployment. In some embodiments, theguide element 319 comprises a coil partial coil, hook, hitch lock systemor snap lock geometry. In some instances, the coil dictates the strengthof the spreading force of the anchor strut 322 radially outwardly.

FIG. 40 illustrates the treatment device 10 of FIG. 39 mounted on thedelivery system 301 of FIG. 38 . As shown, the treatment device 10 ismountable on the bronchoscope 20, deployment sleeve 311 and guidewire313. In particular, the most distal portion of the system 301 isadvanced through the central lumen of the treatment device 10, from thestabilizing end 16 toward the tissue gathering end 14. Thus, the tissuegathering end 14 of the treatment device 10 faces distally. In someembodiments, the stabilizing end 16 and midsection 18 are mounted on theexterior of the bronchoscope 20. In some embodiments, portions of thetissue gathering end 14 are also mounted on the exterior of thebronchoscope 20. For example, in some embodiments the alignment element320 is mounted on the bronchoscope 20, as shown in FIG. 40 . In thisembodiment, portions of the tissue gathering end 14 extend beyond theinsertion cord tip 208 of the bronchoscope 20. In particular, the guideelement 319 is mounted on the guidewire 313 and held in place by thedeployment sleeve 311. This is achieved by having the inner diameter ofthe guide element 319 smaller than the outer diameter of the deploymentsleeve 311 so that the guide element 319 abuts the deployment sleeve311.

The delivery system 301 and mounted treatment device 10 are thenadvanceable into the lung anatomy, the guidewire 313 guiding the system301 through the lung passageways. Once the target location has beenreached, the delivery system 301 is positioned so as to seat thestabilizing end 16 at a desired location, such as within an ostium OS.FIG. 40 illustrates the tissue stabilizing end 16 within an ostium OS ata bifurcation of two lung airways AW. Here, at least a portion of thestabilizing end 16 resides in the ostium OS while the midsection 18 andtissue gathering end 14 extend into the target airway AW. Thus, theflared configuration of the stabilizing end 16 anchors the stabilizingend 16 within the ostium OS by pressing against the walls W of theairway AW.

The treatment device 10 is then deployed within the target airway AW byadvancing the delivery system 301, as illustrated in FIG. 41 . Since thestabilizing end 16 is anchored within the ostium OS and the treatmentdevice 10 has a structure which allows elongation along its longitudinalaxis 19, advancement of the delivery system 301 pushes the tissuegathering end 14 further along the target airway AW while the treatmentdevice 10 expands. In particular, the extendible midsection 18 lengthelongates and stores elastic recoil strain energy in its helixstructure; the elastic strain energy will be used to urge the treatmentdevice 10 to recover to its original shorter length after the device 10has been fully deployed and the delivery system 301 has been decoupledfrom the device 10.

FIG. 42 illustrates the beginning stages of decoupling the device 10from the delivery system 301. To begin, the tissue gathering end 14 isunmounted from the bronchoscope 20. In particular, the alignment element320 is released from the bronchoscope 20, such as by retracting thebronchoscope 20 or by advancing the deployment sleeve 311 which in turnadvances the anchor strut 322 which pulls the alignment element 320 offthe insertion cord tip 208. The guidewire 313, and optionally thedeployment sleeve 311, are held in a fixed position within the airway AWso as to maintain the elongated configuration of the treatment device10. Release of the alignment element 320 allows the anchor strut 322 toextend radially outwardly toward its biased configuration. Thus, asshown in FIG. 42 , the anchor strut end 321 engages with the wall W ofthe airway AW in an anchoring manner. In this embodiment, at least theanchor strut end 321 deforms a portion of the wall W to make purchase ata location that is distant from the stabilizing end 16.

FIG. 43 illustrates further steps of decoupling the device 10 from thedelivery system 301. Here, the deployment sleeve 311 and guidewire 313have been removed from the bronchoscope 20 allowing the tissue gatheringend 14 to fully engage with the wall W of the airway AW. Thus, thetissue gathering end 14 is fixed to lung tissue within the target airwayat a position distant from the stabilizing end 16 within the ostium OS.The bronchoscope 20 can then be fully retracted and removed from thelung anatomy, leaving the treatment device 10 behind, as illustrated inFIG. 44 .

The stored elastic strain energy of the extendible midsection 18, andoptionally any stored energy in the stabilizing end 16 and/or tissuegathering end 14, creates an urging force to recoil and shorten thetreatment device 10 toward its original configuration and length. Sincethe strength of the airway AW is compromised, the walls W are unable toovercome this urging force. Thus, the wall W, at least at the point ofpurchase or engagement by the tissue gathering end 14, is carried withthe tissue gathering end 14 toward the stabilizing end 16. Thisretensions the airway distal to the treatment device 10. FIG. 45illustrates the treatment device 10 after the stored elastic strainenergy that has been stored in at least the midsection 18 of thetreatment device 10 has urged the device 10 to shorten and recoverelastically more closely to its original pre-elongated length. Asdescribed, this shortens the length of the airway along the treatmentdevice 10 yet elongates the length of the airway distal to the treatmentdevice 10 to cause restoration of lung tissue tension and elastic recoilin the tissue that is distal, proximal and adjacent to the treatmentdevice 10. By tensioning the lung tissue, the device 10 has tensionedthe entire bronchial tree that is distal to this single airway which inturn expands the associated alveoli tissue. By tensioning the airwaysand alveoli, the involved airways are held in a dilated arrangement. Insome instances, this simulates the effects of bronchodilator drugs inpatients who still respond to this family of drugs (unfortunately, theselate stage severe emphysema and COPD patients typically no longerrespond to these drugs).

It may be appreciated that the delivery system 301 of FIG. 38 may beused to deliver treatment devices 10 in a variety of ways. One such way,which was illustrated in FIGS. 40-43 , involves seating the stabilizingend 16 in an ostium, or other stable portion of the lung anatomy, andadvancing the stabilizing end 14 further along the airway. It may beappreciated that the treatment devices 10 may be delivered byalternative methods. For example, the tissue gathering end 14 may bepositioned at a target location and the stabilizing end 16 retracted toan ostium, or other stable portion of the lung anatomy. This may beachieved with the use another embodiment of the delivery system 301,such as illustrated in FIG. 46 .

FIG. 46 illustrates another embodiment of a delivery system 301 fordelivery of a treatment device 10. In this embodiment, the deliverysystem comprises a bronchoscope 20 (having a bronchoscope body 200 andan insertion cord 202), a guidewire 313, a deployment sleeve 311 and aguide sleeve 327. In some embodiments, the guide sleeve 327 has aproximal end 328, a distal end 330 and length extender catch feature 329near its distal end 330. In this embodiment, the catch feature 329comprises a protrusion which extends radially outwardly from the guidesleeve 327. The protrusion may have a variety of shapes including aflap, a hook, a knob, a nub, a clasp or any suitable shape for attachingto the treatment device 10 itself or a corresponding feature on thetreatment device 10. The guide sleeve 327 is position able over theinsertion cord 202 of the bronchoscope 20 as shown and is able to slidelongitudinally over the insertion cord 202. In addition, the catchfeature 329 is configured to removably attach to the treatment device10, such as the stabilizing end 16 of the treatment device 10, so thattranslation of the guide sleeve 327 along the insertion cord 202 of thebronchoscope 20 adjusts the treatment device 10 length. For example,retraction of the guide sleeve 327 (toward the proximal end of thebronchoscope 20) increases the length of the device 10 by pulling thestabilizing end 16 proximally. This in turn increases the stress andstrain on the treatment device 10. Such retraction can be undertaken toachieve any desired treatment device stress, strain and lengthconfigurations before advancing the treatment device 10 into the lung,while advancing the treatment device 10 in the lung, just beforedeployment of the treatment device 10 in the lung, after anchoring thestabilizing end 16, after anchoring the tissue gathering end 14, afteranchoring both the stabilizing end 16 and the tissue gathering end 14,or before or after any combination of these actions to deploy thetreatment device 10 in lung tissue. It may be appreciated that in otherembodiments the guide sleeve 327 may be advanced to push the treatmentdevice 10 off of the insertion cord 202 or the guide sleeve 327 may beheld fixed to support the stabilizing end 16 of the treatment device 10to keep the treatment device 10 from binding with the insertion cord202. Further, it may be appreciated that the guide sleeve 327 may beused to pull the treatment device 10 out of the airway while theinsertion cord 202 is being withdrawn from the treatment device.

FIG. 47 illustrates an embodiment of a treatment device 10 releasablymounted on the delivery system of FIG. 46 . As shown, the guide sleeve327 is advanced over the insertion cord 202 and disposed proximal to theinsertion cord tip 208. The treatment device 10 is mounted on thebronchoscope 20 so that the tissue gathering end 14 is disposed over theinsertion cord tip 208 and the stabilizing end 16 is disposed over aportion of the guide sleeve 327. Here, the catch feature 329 engages thestabilizing end 16, such as by hooking on to one or more turns of thecoil forming the stabilizing end 16. This constrains the stabilizing end16 so it cannot use stored elastic spring energy to open and increasethe longitudinal dimension of the treatment device 10. In addition, aguidewire 313 has been advanced through the working channel port 204 ofthe bronchoscope 20 and through the guide coil 319 to guide theadvancement of the system 301. Likewise, the deployment sleeve 311 hasbeen advanced through the working channel 210 of the bronchoscope 20 andit is butted against the guide coil 319. As mentioned, the guide sleeve327 and catch feature 329 has been connected to the stabilizing end 16and adjusted relative to the bronchoscope 20 so the midsection 18 isfixed in an unstressed and unstrained configuration to allow thedelivery system 301 and the treatment device 10 to remain unstressed andflexible during delivery for easy advancement to a treatment location.

Once the delivery system 301 has been advanced to the treatment locationwithin the lung anatomy, the tissue gathering end 14 is desirablypositioned within the treatment location. The tissue gathering end 14will substantially remain in this desired position while the stabilizingend 16 is retracted. To accomplish this, the tissue gathering end 14 isunmounted or deployed from the bronchoscope 20. In particular, thealignment element 320 is released from the bronchoscope 20, such as byretracting the bronchoscope 20 or by advancing the deployment sleeve 311which in turn advances the anchor strut 322 which pulls the alignmentelement 320 off the insertion cord tip 208. The guidewire 313, andoptionally the deployment sleeve 311, are held in a fixed positionwithin the airway AW so as to maintain the elongated configuration ofthe treatment device 10. Release of the alignment element 320 allows theanchor strut 322 to extend radially outwardly toward its biasedconfiguration. Thus, the anchor strut end 321 engages with the wall W ofthe airway AW in an anchoring manner. In this embodiment, at least theanchor strut end 321 deforms a portion of the wall W to make purchase atthe desired location.

The stabilizing end 16 is then retracted, as illustrated in FIG. 48 .Here, the guide sleeve 327 and catch feature 329 has been retractedrelative to the insertion cord 202, pulling the stabilizing end 16proximally so that the extendible midsection 18 is elongated. Thisallows the stabilizing end 16 to be positioned within an ostium or otherstable area within the airway. The treatment device 10 is then releasedfrom the delivery system 301. The stored elastic strain energy of theextendible midsection 18, and optionally any stored energy in thestabilizing end 16 and/or tissue gathering end 14, creates an urgingforce to recoil and shorten the treatment device 10 toward its originalconfiguration and length. Since the strength of the airway AW iscompromised, the walls W are unable to overcome this urging force. Thus,the wall W at least the point of purchase or engagement by the tissuegathering end 14 is carried with the tissue gathering end 14 toward thestabilizing end 16. This re-tensions the airway distal to the treatmentdevice 10. By tensioning the lung tissue, the device 10 has tensionedthe entire bronchial tree that is distal to this single airway which inturn expands the associated alveoli tissue.

FIG. 49 illustrates another embodiment of a treatment device 10. In thisembodiment, the treatment device 10 has a tissue gathering end 14 andextendible midsection 18 which is similar to the device 10 of FIG. 39 ,however in this embodiment the stabilizing end 16 differs. In thisembodiment, the stabilizing end 16 is configured to resist movementrelative to the lung tissue in the distal direction. The stabilizing end16 is comprised of elastic material that is capable of storing elasticstrain energy and recovering to its initial stable shape. In thisembodiment, the initial shape of the stabilizing end 16, illustrated inFIG. 49 , comprises a plurality of loops which splay or deploy radiallyoutwardly due to stored elastic strain energy. In this embodiment, thestabilizing end 16 comprises a body strut 331, an extension loop 336, aspring loop 335, an anchor strut 334, an actuation loop 333, and ananchor strut end 332. The body strut 331 is generally aligned with thelongitudinal axis 19 of the device 10. The extension loop 336 is used totether the device 10 to the delivery device 301. Alternatively, thedelivery device may be a guidewire. The anchor strut 334 is joined withthe body strut 331 by the spring loop 335 which biases the anchor strut334 radially outward at an angle θ, such as between 5 and 90 degrees,preferably about 45 degrees. The stabilizing end 16 is strained, againstits stable shape configuration, during delivery with the delivery device301 retaining the spring loop 335 and the actuation loop 333 in acondition that is coaxial with the longitudinal axis 19. This keeps theanchor strut end 332 from being forced against lung tissue until theuser is ready to deploy the stabilizing end 16.

FIG. 50 illustrates the treatment device 10 of FIG. 49 loaded onto adelivery system 301. In this embodiment, the delivery system 301comprises a bronchoscope 20 (including a bronchoscope body 200 and aninsertion cord 202), a guidewire 313, a deployment sleeve 311 and aguide sleeve 346. The guide sleeve 346 has a proximal end 342 and adistal end 343. The guide sleeve 346 is position able over the insertioncord 202 of the bronchoscope 20 as shown and is able to slidelongitudinally over the insertion cord 202. FIG. 50 illustrates thedelivery system 301 advanced into lung anatomy so that the treatmentdevice 10 has been advanced through airway A and into airway B via abifurcation BF which also leads to airway C. The tissue gathering end 14and stabilizing end 16 are constrained from actuating by the insertioncord 202 which is holding the alignment element 320 and the actuationloop 333 coaxial with the longitudinal axis 19.

FIG. 51 illustrates deployment of the tissue gathering end 14 withinairway B. In this embodiment, deployment is achieved by advancing thedeployment sleeve 311 so as to contact the guide coil 319. Additionaladvancement causes guide coil 319 and attached anchor strut 322 to pullthe alignment element 320 off of the insertion cord tip 208 of thebronchoscope 20. Alternatively, in other embodiments, deployment isachieved by retracting the insertion cord tip 208 while maintainingposition of the deployment sleeve 311 so that the alignment element 320is pulled off of the insertion cord tip 208. In either situation, thisreleases the stored elastic strain energy in the tissue gathering end 14driving the anchor strut end 321 into the airway wall W to anchor thedistal end of the treatment device 10 at the desired location in airwayB, as described previously in relation to the embodiment of FIG. 39 . Itmay be appreciated that in some embodiments the alignment element 320 isconfigured as a structure that only partially encircles the bronchoscopeshaft 202 as shown in FIG. 51 wherein the anchor loop 320 has an opening354 and the loop 320 is then turned back around to form a blunt partialloop termination 355. It may be appreciated that the proximal anchorspring loop 335 and the proximal anchor actuation loop 333 may besimilarly formed so as to not fully encircle the bronchoscope and stillbe effective. This allows for a bronchoscope or other delivery cannulaor delivery device shaft, such as a guidewire, that may have diametervariation down the length to be translated to activate or unlock theseanchor assemblies without actually removing the bronchoscope or deliverycanula or delivery element. The proximal extension loop 336 is utilizedfor connection to a wire, link or tether 344 which may be pulled to movethe device 10 or the stabilizing end 16 more proximally so as to extendthe length of the midsection 18 while the device 10 is anchored into thelung tissue. The tissue gathering end 14 is configured to resist movingproximally in relation to the airway wall W, but it is configured toeasily be moved more distally relative to the airway wall W. Thestabilizing end 16 is configured to resist being advanced distally inrelation to the airway wall W but it is configured to be able to bemoved proximally relative to the airway wall W thereby extending themidsection 18.

The midsection 18 is extended, as illustrated in FIG. 52 . In someembodiments, such extension is achieved by retracting the guide sleeve346 which has a tether 344 extending therethrough. The tether 344 isremovably attached to the extension loop 336 of the device 10, asmentioned previously. Retraction of the guide sleeve 346 pulls thetether 344 which in turn pulls the stabilizing end 16 of the device 10.In other embodiments, the guide sleeve 346 remains in place and thetether 344 is retracted into or through the guide sleeve 346. In someembodiments, this is achieved by pulling a handle 351 which is attachedto the tether 344. FIG. 52 illustrates an embodiment of such a handle351. Here, the handle 351 comprises a shaft 353 having a hole 352therethrough. The tether 344 has two free ends which extend through oralong the guide sleeve 346, exiting the proximal end 342 of the guidesleeve 346. The free ends wrap around the shaft 353 of the handle 351and through the hole 352 to increase traction and efficiency whenpulling the tether 344. Thus, as the handle 351 is pulled away from thepatient, the tether 344 is tensioned and pulls on the extension loop 336of the device 10. By tensioning the tether 344, the tether 344,treatment device 10 and airway wall W become a tensile member whichstraightens the tether 344, the treatment device 10 and the airway wallW.

The pulling force is translated through the device 10 to the tissuegathering end 14. If the tissue gathering end 14 is anchored in stablelung tissue, the tissue gathering end 14 will remain in place and themidsection 18 will expand longitudinally as the stabilizing end 16 movesin the proximal direction. If the tissue gathering end 14 is anchored inunstable or weakened lung tissue, the tissue gathering end 14 will pullthe weakened airway wall W along with it in the proximal direction asthe stabilizing end 16 moves in the proximal direction. This willcontinue until stronger lung tissue is reached wherein the tissuegathering end 14 will cease movement and the midsection 18 will expandlongitudinally as the stabilizing end 16 moves in the proximaldirection. The midsection 18 is extended until the stabilizing end 16 isdesirably positioned within the airway. The stabilizing end 16 is thenreleased and anchored in place.

FIG. 53 illustrates anchoring of the stabilizing end 16 within theairway B, just beyond the branch to airway C. This is achieved byretracting the bronchoscope 20 from the device 10. Such retractionreleases the spring loop 335 of the device 10. As mentioned previously,the spring loop 335 joins the body strut 331 with the anchor strut 334which is biased radially outward. Thus, release of the spring loop 335allows the anchor strut 334 to extend radially outwardly, toward theairway wall W, such as shown. The anchor strut end 332 engages theairway wall W, anchoring the stabilizing end 16 in place.

FIG. 54 illustrates the treatment device 10 after the tether 344 hasbeen cut and removed. Removal of the pulling force from the tether 344allows the midsection 18 to recoil toward its natural configuration overtime. Since the stabilizing end 16 and the tissue gathering end 14 areengaged with the airway walls W, the engaged portions of the airwaywalls W travel along with the ends 14, 16. In some embodiments, bothends 14, 16 travel toward each other as the longitudinal length of themidsection 18 shortens. Thus, the lung tissue along the airway betweenthe ends 14, 16 becomes minimally compressed, as illustrated in FIG. 54, and the volume of the lung along the airway B becomes minimallyreduced. The airway between the ends 14, 16 is supported by the helicalstructure of the midsection 18, acting as a stent to keep the airwaypatent. Thus, COPD symptoms are reduced rather than increased, which isthe result when the airways are compressed without internal support,exasperating the original problem in the lung particularly duringexpiration breathing cycles. In addition, the more proximal airway Astructure and the proximal end of airway B structure is now stronger andprovides a better foundation and base to stabilize lung tissue and lungtreatment devices than the distal end of airway B.

It may be appreciated that in some embodiments the ends 14, 16 travelequal distance toward the center of the midsection 18. In otherembodiments, the ends 14, 16 travel differing distances, such asinfluenced by the stability of the portions of the airway wall W engagedby the ends 14, 16. For example, the stabilizing end 16 is typicallypositioned more proximally than the tissue gathering end 14, within aportion of the airway that is stronger and more stable. In suchinstances, the stabilizing end 16 would travel a smaller distance thanthe tissue gathering end 14 which is engaged with weaker tissue. It mayalso be appreciated that in some embodiments, only one of the ends 14,16 moves while the other remains stationary. In such instances,typically the tissue gathering end 14 moves toward the stabilizing end16. However, the outcome would vary depending on the characteristics ofthe airway and the treatment device 10. It may also be appreciated thatas the health of the patient changes over time, such as a progression ofthe disease state, the device 10 will continue to shorten so as tomaintain tension in the lung.

FIG. 55 illustrates the elastic recoil of the treatment device 10causing midsection 18 shortening as has been previously discussed. FIG.55 also illustrates the branching of the distal portion of airway B intoan attached network of airways D, E (F is the cross-section of thedistal portion of airway B). The airways B, D, E that are longitudinallytensioned and affected by the deployment, elongation and tensioning ofthe treatment device 10. The distal portion of airway B is shown to besupported and made to remain round and patent as the patientsuccessfully expires air as connective tissue between the distal airwaysD and E connect to the distal portion of airway B to hold the distalportion of airway B more open and round (as shown in F) as tension isapplied to the entire lung airway system. By tensioning the lung tissueto support the airway tree A, B, C, D, and E in tension, the symptomslisted herein are reduced and one or more of the physiologic changesthat are listed in herein are changed to beneficially affect and treatCOPD patients who may suffer from emphysema. FIG. 56 illustrates analternative method to treating the patient wherein the device 10 isdeployed in the lung anatomy and then expanded thereafter. In thisembodiment, the treatment device 10 is similar to that of FIG. 49 and isdeployable by a delivery device 301 into an airway of the lung. In thisembodiment, the device 10 is partially deployed according to FIGS. 50-51, wherein the tissue engaging end 14 is deployed and engaged with theairway wall W. However, in this embodiment, the stabilizing end 16 isalso deployed without extending the midsection 18. This may be achievedby retracting the bronchoscope 20 while the guide sleeve 346 is heldagainst the stabilizing end 16 so that the stabilizing end 16 isreleased and deployed. Thus, the device 10 is deployed into the airwayin a substantially relaxed configuration, as illustrated in FIG. 56 .

The device 10 maintains connection with the tether 344 which extendsthrough or along the guide sleeve 346. It may be appreciated that theconfiguration of the tissue gathering end 14 and its engagement with thewall W creates resistance to movement of the device 10 along the airwayin the proximal direction. In particular, the anchor strut 322 extendsradially outwardly from the longitudinal axis 19 forming an angle θwhich faces the proximal direction or midsection 18. Likewise, anchorstrut end 321 faces the proximal direction or midsection 18 as itengages the wall W. This creates an indent in the wall W and a tissueledge which impedes movement of the anchor strut end 321 along the wallW in the proximal direction. Likewise, the configuration of thestabilizing end 16 and its engagement with the wall W creates resistanceto movement of the device 10 along the airway in the distal direction.In particular, the anchor strut 334 extends radially outwardly from thelongitudinal axis 19 forming an angle θ which faces the distal directionor midsection 18. Likewise, anchor strut end 332 faces the distaldirection or midsection 18 as it engages the wall W. This creates anindent in the wall W and a tissue ledge which impedes movement of theanchor strut end 332 along the wall W in the distal direction. However,it may be appreciated that either or both of the tissue gathering end 14and stabilizing end 16 are able to move along the airway away from themidsection 18. In this embodiment, the stabilizing end 16 is tethered tothe delivery device 301, particularly the guide sleeve 346. Therefore,the stabilizing end 16 is able to be pulled in the proximal direction bypulling the tether 344. However, the tissue gathering end 14 resistsmovement along the wall W in the proximal direction at least due to thetissue ledge impeding the anchor strut end 321. If the wall W is weak,the wall W itself moves in the proximal direction, being pulled by theanchor strut end 321. This continues until a stronger portion of thewall W is reached which is able to resist longitudinal compression. Atthat point, the tissue gathering end 14 anchors in place and themidsection 18 expands, increasing the overall longitudinal length of thedevice 10. This continues incrementally as the stabilizing end 16 ispulled along the airway. At any time, pulling may cease and thestabilizing end 16 remains engaged at the new location along the wall Wdue to resistance in the distal direction at least due to the tissueledge impeding the anchor strut end 332. Such extension of themidsection 18 stores elastic strain energy in the device 10. Since thewall W has compressed and adjusted during positioning of the stabilizingend 16, the device 10 will likely maintain its length and position uponrelease of pulling force. However, over time, the stored elastic strainenergy may cause the midsection to contract, along with movement of thetissue gathering end 14 and/or stabilizing end 16 toward the midsection18.

It may be appreciated that such capability may allow the length of thedevice 10 to be adjusted throughout the procedure to achieve the desiredre-tensioning of the airway. Once this has been achieved, the tether 344is removed along with the delivery device 301. It may be appreciatedthat in some embodiments the device 10 may be re-accessed andrepositioned. This may be achieved by re-tethering or re-connecting adevice, such as a delivery device 301, to the stabilizing end 16 andfurther pulling the stabilizing end so as to position the stabilizingend 16 at a new more proximal location. This pulling motion furthertensions the airway. Again, once the desired effect has been achieved,the delivery device 301 is removed leaving the device 10 in place.

It may be appreciated that the pulmonary treatment devices 10 may beremoved from the lung anatomy either during the procedure, forrepositioning or replacement, or at a later time during a secondaryprocedure. Removal may be achieved by threading a delivery devicethrough the appropriate portions of the device 10, such as through theactuation loop 333 and/or alignment element 320, so as to re-engage thedevice 10. The device 10 is then pulled proximally by the deliverydevice and extracted from the body. It may also be appreciated that thedevice 10 may be pulled from the anatomy by attachment to any suitableportion, such as the stabilizing end 16, and applying sufficient forcein the proximal direction to withdraw the device 10. The same device 10can then be sanitized and reloaded on the delivery device forre-delivery to the target treatment area or a new device 10 may beutilized.

Likewise, it may be appreciated that previously positioned devices 10may be adjusted at a later time during a secondary procedure. This maybe achieved by accessing a previously positioned device 10 with adelivery device and attaching thereto. This can be achieved by threadinga delivery device through the appropriate portions of the device 10,such as through the actuation loop 333 and/or alignment element 320, soas to re-engage the device 10. Typically, the actuation loop 333 isre-engaged so as to attach to the stabilizing end 16 of the device 10.Or, the stabilizing end 16 is grasped such as with the use of a catchfeature 329. In such instances, the stabilizing end 16 is pulledproximally so as to further re-tension the airway AW. This may bedesired if the disease has progressed over time beyond the ability ofthe device 10 to compensate. The stabilizing end 16 is then secured in anew location to maintain the re-tensioning. The delivery device is thendisengaged from the pulmonary treatment device 10 which is left behindas an implant.

It may be appreciated that a variety of approaches have been describedherein, including treatment devices 10 which are introduced through alumen in a delivery device (including being pushed or pulled through thelumen by itself, within an introducer or mounted on an additional devicesuch as a catheter or guidewire which is advanceable within the lumen),and treatment devices 10 which are introduced by mounting on an exteriorportion of a delivery device, such as the insertion cord tip 208 of abronchoscope 20 or on a catheter, wherein the treatment device 10 ispushed or pulled from the mounted position by an external or internalsleeve or device. It may be appreciated that in some embodiments thetreatment device 10 is deployed as it is released from the deliverydevice and in other embodiments, the treatment device 10 is releasedfrom the delivery device and then deployed, such as by the removal of anelement or device which holds the treatment device 10 in a constrainedconfiguration (e.g. a guidewire or sleeve). It may be appreciated thatin some embodiments, a single treatment device 10 is deliverable from adelivery device at a time and in other embodiments multiple treatmentdevices 10 (including two, three, four, five, six or more) aredeliverable from the delivery device at a time. It may be appreciatedthat the treatment devices 10 may be pre-loaded on or within thedelivery device or may be loaded by the user. It may also be appreciatedthat in some embodiments the tissue gathering end 14 is anchoredinitially in the lung passageway and the stabilizing end 16 is pulled soas to re-tension the airway. In other embodiments, the stabilizing end16 is anchored initially in the lung passageway and the tissue gatheringend 14 is pushed so as to re-tension the airway. It may be appreciatedthat pulling of the stabilizing end 16 or pushing of the tissuegathering end 14 may be achieved while the end 14, 16 is held in acontracted state for ease of movement or after the end 14, 16 has beendeployed (wherein the end 14,16 has been specially designed to allowsuch movement).

FIG. 57 illustrates another embodiment of a treatment device 10. In thisembodiment, the treatment device 10 is optionally introduce able througha lumen in a delivery device. Thus, it is collapsible into a smallprofile. It is held in the collapsed or constrained configuration by theuse of a catheter or guidewire which holds the treatment device 10 inthe constrained configuration. In some embodiments, a guidewire ispreferred due to its small diameter and ability to be advanced intodistant branches of the lung passageways. Once the treatment device 10is desirably positioned within the lung passageway, the guidewire isremoved, thereby allowing the device 10 to deploy either at once or instages.

FIG. 57 illustrates the treatment device 10 in its deployed or expandedstate. In this embodiment, the treatment device 10 has a tissuegathering end 14, unextendible midsection 18 and a stabilizing end 16.The treatment device 10 may have a single component structure or may becomprised of a number of components. In any case, individual stiffnessesof the tissue gathering end 14, extendible midsection 18 and stabilizingend 16 may be tuned to maximize effectiveness of both anchoring andsupporting likeness to healthy lung tissue. Likewise, the tissuegathering end 14 and stabilizing end 16 are flexible so as to collapsealong longitudinal axis 19 and deploy or expand to the relaxedconfiguration shown in FIG. 57 . Such expansion is typically achieved byself-expansion due to spring loading.

FIG. 58 illustrates the treatment device 10 of FIG. 57 in a collapsedconfiguration. Here, the device 10 is mounted on a guidewire 313. Thus,each of the tissue gathering end 14, midsection 18 and stabilizing end16 form at least one loop or partial loop through which the guidewire313 is passable so that the treatment device 10 is mountable on theguidewire 313 and the tissue gathering end 14 and stabilizing end 16 areheld in a constrained configuration (storing elastic strain energy). Inthis collapsed or constrained configuration, the guidewire 313 andtreatment device 10 are passable through a lumen in a delivery device,such as a working channel 210 of a bronchoscope 20. In some embodiments,the guidewire 313 and treatment device 10 are passable through a workingchannel 210 having an inner diameter that is sized between 1.3 and 3.2mm. In this embodiment, the extendible midsection 18 comprises a coilwherein the guidewire 313 is passable therethrough. Thus, the extendiblemidsection 18 is able to be elongated to store elastic strain energywhich urges the treatment device 10 to recover back to a non-elongatedlength. In some embodiments, the midsection 18 has a uniform diameter.However, in other embodiments, the midsection 18 has a taperingdiameter, particularly tapering downward toward the stabilizing end 14of the treatment device 10. Such tapering may mimic the taperingdiameter of a lung passageway within which the device 10 is implanted.

As more easily visualized in FIG. 58 , the tissue gathering end 14comprises a body strut 323, a guide element 319, an anchor strut 322, analignment element 320 and an anchor strut end 321. In this embodiment,the body strut 323 extends from the flexible midsection 18 and isgenerally parallel to the longitudinal axis 19. The body strut 323 isconnected with a guide element 319 which typically forms the distal-mostportion of the treatment device 10. In this embodiment, the guideelement 319 comprises a coil, however the element 319 may have anysuitable shape including a single loop. In this embodiment, the guideelement 319 is arranged so that the guidewire 313 coaxially passesthrough the guide element 319. The guide element 319 also stores thestrain energy which allows the anchor strut 322 to deploy and extendoutwardly. In some instances, the coil dictates the strength of thespreading force of the anchor strut 322 radially outwardly. Duringdelivery and prior to deployment, the anchor strut 322 is held in aretracted or un-extended position so as to avoid dragging along theairway walls W or traumatizing tissue. Such retraction is maintained byalignment element 320. In this embodiment, the alignment element 320 hasthe form of a coil, however it may be appreciated that the element 320may have the form of a single loop, a partial loop or snap lockingstructure, a hook shaped lock or spring lock mechanism, to name a few.When the center of the element 320 is aligned with the longitudinal axis19, the anchor strut 322 is held parallel to or at a small angle inrelation to the longitudinal axis 19. Such alignment is maintained bypassing the guidewire 313 or similar device through the center of thetreatment device 10 and through the alignment element 320 (asillustrated in FIG. 58 ). The tissue gathering end 14 is configured soas to bias the alignment element 320 and attached anchor strut 322radially outwardly. Therefore, withdrawal of guidewire 313 from thealignment element 320 frees the alignment element 320 and allows thealignment element 320 to rotate away from alignment with thelongitudinal axis 19. This, in turn, causes the anchor strut 322 toextend radially outwardly. In some embodiments, the anchor strut 322extends 1 mm to more than 30 mm but 6-12 mm is preferable. The anchorstrut 322 terminates in an anchor strut end 321, which may have avariety of shapes including a coil, ball, sharp end barb, L shaped pad,strain relief long coil or tapered coil, to name a few. The anchor strut322 is configured to extend radially outwardly upon deployment so atleast the anchor strut end 321 engages an airway wall W or damagedtissue DT, such as in the area of the alveolar sacs. However, in someinstances, the anchor strut 322 itself additionally engages the airwaywall W or damaged tissue DT.

In the extended position, the alignment element 320 has an axis which isat an angle θ to the longitudinal axis 19. Typically, the angle θ is inthe range of 1 to 90 degrees, preferably 20-65 degrees. In someembodiments, additional portions of the tissue gathering end 14 are alsobiased to assist in extension of the anchor strut 322 radiallyoutwardly. For example, in some embodiments, the body strut 323 isbiased so as to further extend the anchor strut 322 radially outwardly.In the embodiment of FIG. 39 , the body strut 323 is disposed oppositethe anchor strut 322 so that the alignment element 320 is disposedtherebetween. Thus, when the center of the alignment element 320 isaligned with the longitudinal axis 19, the body strut 323 and anchorstrut 322 reside on opposite sides of the longitudinal axis 19. In someinstances, release of the alignment element 320 allows both the bodystrut 323 and anchor strut 322 to bias toward their relaxedconfigurations (such as pushing both the body strut 323 and anchor strut322 outwardly in the same radial direction). This can allow the bodystrut 323 and anchor strut 322 to spread fully elastically at least 5degrees but up to 90 degrees, and preferably 20 to 65 degrees, to pushthe anchor strut end 321 into or through the wall of an airway or thediseased tissue to anchor the tissue gathering end 14 in the lungtissue.

In this embodiment, the stabilizing end 16 comprises a body strut 331, aspring loop 335, an extension loop 336, an anchor strut 334, anactuation loop 333, and an anchor strut end 332. The body strut 331 andspring loop 335 are generally aligned with the longitudinal axis 19 ofthe device 10 in both the relaxed and constrained configurations. Theanchor strut 334 is joined with the body strut 331 by the spring loop335 which biases the anchor strut 334 radially outward at an angle θ,such as between 5 and 90 degrees, preferably about 45 degrees. Thespring loop 335 also allows the anchor strut 334 to be moved toward thelongitudinal axis 19 so that the actuation loop 333 is aligned coaxiallywith the longitudinal axis 19 for passage of the guidewire 313therethrough. This keeps the anchor strut end 332 from being forcedagainst lung tissue until the user is ready to deploy the stabilizingend 16.

Referring again to FIG. 58 , the treatment device 10 of FIG. 57 is shownloaded onto a guidewire 313. In this embodiment, the delivery systemcomprises the guidewire 313, a pusher coil 370 and a tether 344 that islooped, tied, attached (such as with a hitch knot) or otherwiseremovably attached to the pulmonary treatment device 10, such as toextension loop 336. The pusher coil 370 has a proximal end 372 and adistal end 373. The coil shape allows the pusher coil 370 to bend andflex easily through the anatomy. The pusher coil 370 Is typicallycomprised of a metal material to assist in cleaning and steamsterilization however other materials may be used such as polymers. Thepusher coil 370 is positionable over the guidewire 313, proximal to thetreatment device 10, as shown, and is able to slide longitudinally overthe guidewire 313. To deploy the treatment device 10, the pusher coil370 is advanced over the guidewire 313 so as to push the treatmentdevice 10 in the distal direction while the guidewire 313 remains inplace. Consequently, the treatment device 10 is pushed off of theguidewire 313 wherein it deploys to its relaxed and expandedconfiguration. This may be achieved in stages or all at once. Forexample, in some embodiments, the tissue gathering end 14 is pushed offthe distal end of the guidewire 313 with the use of the pusher coil 370so that the anchor strut 322 expands and at least the anchor strut end321 engages the lung passageway wall. This is achieved while theremainder of the treatment device 10 remains mounted on the guidewire313. The proximal end of the treatment device 10 is then pulled in theproximal direction by applying pulling force to the tether 344. Sincethe tissue anchoring end 14 is anchored in the lung passageway, the lungpassageway is pulled proximally, re-tensioning the airway, while themidsection 18 also expands. Once airway is desirably re-tensioned, thestabilizing end 16 is deployed by advancing the pusher coil 370, therebypushing the stabilizing end 16 off of the guidewire 313. This allows thestabilizing end 16 to anchor in place. The guidewire 313 and pusher coil370 are then removed from the patient. In addition, the tether 344 isremoved from the treatment device 10.

It may be appreciated that the delivery system of FIG. 58 and treatmentdevice 10 mounted thereon may be passed through a lumen of a scope orother instrument, particularly through a working lumen of a bronchoscope20. Or, the delivery system of FIG. 58 and treatment device 10 mountedthereon can be advanced through the trachea and into the lung by itself,without the use of a bronchoscope.

Torque-Based Pulmonary Treatment Device Embodiments Torque-BasedTreatment Overview

The above described embodiments rely primarily on linear or curvilinearpulling and pushing of lung tissue to re-tension the lung in patientssuffering from COPD, particularly advanced COPD where tissue is highlydamaged. Here, methods and devices are provided which rely primarily ontorque, twisting and rotation to re-tension the lung, optionally inaddition to linear or curvilinear pulling and pushing. Such embodimentsare particularly suitable for patients with advanced emphysema, such aspatients who are diagnosed as GOLD stage II, III, and IV, where the lungcontains highly damaged tissue, particularly into and well beyond thelobar airways and typically beyond the bifurcations that lead to regionsof the lung that would normally contain the 3rd generation airways ormore distal generations of airways in a healthy person. Lung airways andbronchi are comprised of smooth muscle, submucosa, mucosa, connectivetissue made of collagen, a subepithelial basement membrane andepithelium. Among other things, the COPD disease progresses to allowenzymes to dissolve bronchi, airway components and complete airways. Thedisease also destroys elastin in tissue that survives the enzymatic bulkreduction of airways and lung tissue. Late stage Emphysema patient lungsare compromised to the point that these patients commonly communicategases through paths or passageways that are largely without airways. Inthese areas of damaged tissue, large portions of parenchyma are oftenloose or missing, forming coalesced blebs and bullae. Thus, normal lungpassageways with supportive walls are typically not available, and anyexisting tissue is sponge-like. These pulmonary treatment devices andmethods consider the vast tissue damage of advanced COPD sufferers andare designed specifically to treat these patients. It may be appreciatedthat although the previously described pulmonary treatment devices relyprimarily on linear or curvilinear pulling and pushing of lung tissue totreat the lung, particular embodiments may also be used to apply torqueto the lung tissue in such treatment.

FIG. 59A illustrates an example of a torque-based pulmonary treatmentdevice 400 and FIG. 59B illustrates the treatment device 400 deployedinto a lung L. Referring to FIG. 59A, in this embodiment the device 400comprises a tissue gathering element 402 and an anchoring element 404,both of which join with an attachment end 406. The attachment end 406may be used to attach a delivery device thereto, such as a torqueingtool 408. Thus, the attachment end 406 typically has a non-roundcross-section shape, such as a square, rectangular, polygonal or ovalshape, to assist in maintaining rotational torque coupling and torquetransmission during rotational or torqueing motion of the torqueing tool408. It may be appreciated that in some embodiments the attachment end406 is formed from portions of the tissue gathering element 402 andanchoring element 404 themselves, such the joining of their respectiveproximal ends. In other embodiments, the attachment end 406 includes anattachment element 410 to assist in joining the elements 402, 404 andforming a desired shape for attachment and torqueing. And yet in otherembodiments, the attachment end 406 resides at the proximal end of thetissue gathering element 402 or the anchoring element 404 and theelements 402, 404 are joined to each other distally of the attachmentend 406.

In this embodiment, the tissue gathering element 402 is comprised of ashaft 412 extending in a first direction from the attachment end 406 andthen bending laterally outwardly in a second direction to form acircular, inwardly spiraled shape. The shaft 412 may reside in a singleplane (e.g. x-y plane) or may pass through additional planes throughoutthe spiral shape (e.g. in the z direction) so that portions of the shaft412 reside out of the x-y plane. Typically, the tissue gathering element402 has a shape which is approximately 0.25 to 3 inches in diameter,preferably approximately 0.5 to 1.5 inches in diameter. In thisembodiment, the shaft 412 is comprised of wire, such as metal (e.g.nitinol, austenite or martensite nitinol, spring steel, stainless steel,cobalt steel alloys, titanium etc.) or polymeric compounds, ceramic,carbon fiber and/or other biocompatible materials. Such wire istypically extruded, drawn or sintered into near net shapes or wire formshapes, wherein the wire has a constant diameter between 0.005 inches upto 0.200 inches but preferably round wire between 0.013 and 0.070 inchesin diameter or ribbon wire that is 0.005 to 0.040 inches thick and 0.010to 0.100 wide. The ribbon width or thickness may be different at thedistal tissue gathering element 402 as compared to the proximalanchoring element 404. In some embodiments, the distal tissue gatheringelement 402 is made from ribbon that is 0.015 to 0.030 inches thick and0.045 to 0.080 inches wide while the and the proximal anchoring element404 is made from ribbon that is 0.010 to 0.030 inches thick and 0.010 to0.030 wide. In some embodiments, the shaft 412 is comprised of a singlewire and in other embodiments, the shaft 412 is comprised of more thanone wire (such as twisted together) and/or includes additional featuresand/or elements to increase its diameter and/or increase its ability togather lung tissue, as will be described in later sections. It may beappreciated that the one or more wires may have any suitablecross-sectional shape including round, oval, square, rectangular, etc.Further, the one or more wires may have a cross-sectional shape whichchanges along the length of the shaft 412. Likewise, the one or morewires may be made from tapered wire or wire that varies in diameter atdifferent locations along the tissue gathering element 402. It may beappreciated that the tissue gathering element 402 may be comprised ofany combination of these materials and geometries. In other embodiments,the shaft 412 includes additional features and/or elements to increaseits diameter and/or increase its ability to gather lung L tissue, aswill be described in later sections.

In this embodiment, the anchoring element 404 is comprised of a shaft412 which extends from the attachment end 406, as shown in FIG. 59A, inthe same direction as the tissue gathering element 402, generally alonga longitudinal axis 411. In this embodiment, the shaft 420 of theanchoring element 404 bows outwardly, away from the longitudinal axis411 and tissue gathering element 404, such as to form the shape of abifurcation. This bifurcation typically mimics the bifurcations found inthe airway network branches from the trachea through the variousportions of the lung L. In some embodiments, this aspect allows theanchoring element 404 to anchor the device 400 in the lung anatomy.

Referring to FIG. 59B, the treatment device 400 is sized and configuredto be delivered through a delivery device which is insertable into thelung L, such as a steerable scope (e.g. bronchoscope 20). In thisembodiment, the device 400 is loaded within a catheter 430 or similardelivery device which is advanceable through a lumen in the bronchoscope20. During such advancement, the device 400 is constrained within thecatheter 430 to allow for ease of movement. In this embodiment, suchconstraint is achieved by retraction of the device 400 of FIG. 59A intoa lumen in the catheter 430 so that the anchoring element 404 and tissuegathering element 402 are drawn together and the tissue gatheringelement 402 is uncoiled and straightened. The device 400 remains withinthe catheter 430 until the distal tip of the catheter 430 is desirablypositioned within the lung L.

In some embodiments, the distal tip of the catheter 430 is advancedbeyond the distal tip of the bronchoscope 20. This allows the catheter430 to reach locations that are beyond the reach of the bronchoscope 20due to size constraints (i.e. the smaller diameter of the catheter 430can pass through small diameter or contorted passageways that the largerdiameter bronchoscope is restricted from entering). Thus, in someinstances, the catheter 430 is able to reach far distal portions of thelung L, such as the apical portions of the upper lobes and the lateralcorners of the lower lobes, which are typically unreachable by thebronchoscope alone.

In some embodiments, the catheter 430 is advanced with the use of aguidewire. This may be within an airway or beyond the natural airwaysinto damaged tissue, parenchyma, alveoli, artificially createdpassageways or other types of lung tissue. In such instances, the device400 is not pre-loaded into the catheter 430, rather the device 400 isinserted at a later time once the catheter 430 is desirably positioned.This is because the guidewire typically fills the catheter lumen. Theguidewire fills the catheter lumen so as to minimize digging of thecatheter leading edge into tissue during advancement and to provide aflexible, blunt, atraumatic tip. The guidewire then acts as a rail orsupport shaft to further advance the catheter 430. Alternatingadvancement of the guidewire and catheter in blood vessels is known asthe Seldinger Wire Technique. In some embodiments, the guidewire andcatheter 430 are advanced within the lung using a modified SeldingerWire Technique. It may be appreciated that when using a guidewire, thedelivery system components may be configured to be deliveredOver-The-Wire (OTW) or Rapid Exchange (RX). In an OTW design, theguidewire exits the delivery system at its proximal end so that theguidewire that tracks along the full length of the delivery device. Incontrast, in the RX design, the guidewire exits the delivery system at aside port. Thus, the guidewire only tracks along a short section (about25 cm) of the delivery device and then exists at the side port. Thisdesign saves time compared with advancing a guidewire through the fulllength of the delivery device.

It may be appreciated that the guidewire is configured to be compatiblewith advancement within lung tissue, particularly to contact lung tissuewith minimal or no incident or injury. In some embodiments, theguidewire is comprised of a wire cable, wire bundles, continuous braid,twisted wire, or twisted wire bundle shaft structure with blunt tip(typically formed by crimping, gluing or welding the tip of theguidewire shaft structure). In some embodiments, the guidewire has adiameter in a range of 0.005 to 0.100 inches, preferably in a range of0.018 to 0.070 inches. Typically, the guidewire fills the catheter lumenin a way that presents no gaps or very minimal gapping while theguidewire is curved or bent during delivery. In some embodiments, theguidewire is configured so that no portion of the guidewire whichcontacts tissue creates a gap which opens more than 0.030 inches,preferably in a range of 0 and 0.020 inches during bending around aradius that is 0.5 inches or smaller, to minimize catching tissue in thegaps. This is in contrast to conventional vascular guidewires made witha central core wire and a coiled spring outer jacket. When such vascularguidewires are used in the lung, the adjacent coils in the coil springjacket tend to separate more than 0.030 inches which creates gaps thatallow lung tissue to intrude and be caught during bending through lungpassageways. Thus, when the vascular guidewire is retracted, thepulling/withdrawing motion straightens the wire and closes the gaps morethan 0.001 inches smaller which causes the lung tissue to be pinched orcaught in the coil spring jacket. Such outcomes are avoided with thespecially configured guidewire embodiments described herein.

Once the distal tip of the catheter 430 is positioned near a targetlocation for placement of the treatment device 400, the device 400 isdeployed. If a guidewire was used, the guidewire is removed and thedevice 400 is inserted and advanced through the catheter 430 using apusher, cable, or link, such as torqueing tool 408. In some embodiments,the torqueing tool 408 is attachable to the device 400 near theattachment end 406, and in other embodiments the torqueing tool 408 isattachable at a location between the tissue gathering element 402 andthe attachment end 406.

Deployment from the catheter 430 may be achieved by a variety of methodsor a combination of multiple methods. In some embodiments, the device400 is self-expanding. In such instances, the catheter 430 may beretracted to expose the device 400. Once exposed, the device 400self-expands, tending toward its pre-formed or natural configuration.Alternatively, the device 400 may be advanced beyond the distal tip ofthe catheter 430 allowing self-expansion, again due to release oftension or compression. In either case, the self-expanding device 400 isrecovered to a programmed or pre-bent curved shape. When the device 400is comprised of nitinol, the super-elastic or pseudo-elastic propertiesof nitinol force the curved shape to recover. When the device 400 iscomprised of a memory shape alloy, the heat energy provided by the bodytemperature of the patient causes the device 400 to resume apre-programmed curved shape. In other embodiments, the device 400 is notself-expanding. For example, in some embodiments the tissue gatheringelement 402 is bent into a deployed shape within the lung L by the useror the tissue gathering element is actuated into a deployed shape by useof a mechanical mechanism, such as a mechanism that bows the tissuegathering element 402 (e.g. by retracting a suture that is attached tothe distal most tip of the tissue gathering element 402).

Deployment allows the distal tip of the tissue gathering element 402 toengage the surrounding tissue, curving through and/or against thetissue. Such deployment may be in an airway or beyond the naturalairways into damaged tissue, parenchyma, alveoli, artificially createdpassageways, disease created passageways or other types of lung tissue.It may be appreciated that the distal tip of the tissue gatheringelement 402 may be sharp or blunt, including a ball tip or other shapes.The ability to pierce the tissue may be due to a combination of factors,including tissue type, tissue condition and tip shape, to name a few.Thus, in some embodiments, the tissue gathering element 402 piercesthrough lung tissue during deployment from the catheter 430 and in otherembodiments the tissue gathering element 402 deploys within the tissuewithout piercing. And, in some embodiments, the tissue gathering element402 pierces some tissue and not other tissue. In any case, the deployedtissue gathering element 402 has an expanded configuration within thelung L.

The device 400 is then rotated, as illustrated in FIG. 60 . Rotation isachieved by applying torqueing, twisting or rotational force to at leasta portion of the device 400 with the use of the torqueing tool 408 orother such device. In some embodiments, the torqueing tool 408 includesa handle 435 which is graspable by a user so as to manually applying therotational force. Since the torqueing tool 408 is attached to the device400, the device 400 (and therefore tissue gathering element 402) rotatesas well. The arrows indicating rotation of the proximal and distal endof the torqueing tool 408 in FIG. 60 indicate that the torqueing tool408 may be rotated both clock-wise or counter clock-wise directions.This gathers up the surrounding lung tissue onto and around the tissuegathering element 402 as the element 402 rotates, such as like twistinga fork in spaghetti to gather the spaghetti onto the fork. Thus, looseparenchyma, portions of blebs and bullae, damaged alveolar sacs andother distended, slackened or stretched tissue is pulled inwardly,twisted and/or gathered up by the tissue gathering element 402. Rotationcontinues, gathering the loose, slackened tissue, until tension isachieved in the tissue. With each additional rotation, the lung tissuewill be increasingly strained or tensioned. Likewise, the diameter oftissue that is spooled up around the tissue gathering element 402 willgrow to further improve the effectiveness of the device 400. In someinstances, as lung parenchyma is gathered around the tissue gatheringelement 402, it is compressed around the tissue gathering element 402and/or compressed between layers of tissue that is wrapped around thetissue gathering element 402. It may be appreciated that the device 400may be effective at gathering, tensioning or compressing lung tissueeven if there is no compression of tissue or lung volume reduction thatis performed within the center of the distal tissue gathering element402 or within coils of a helix shape.

Recall, it is the inward pulling tension of the lung tissue that liftsthe diaphragm and is balanced by the outward recoil pressure or outwardpulling of the chest wall. The lung is suspended in an expanded statedue to negative pressure or vacuum between the chest wall and theexterior lining of the lung. This vacuum keeps the lung expanded andpinned to the chest wall. Because the lungs are held in a generallyexpanded state, applying torque with the device 400 in the interior ofthe lung L stresses and tensions diseased lung tissue (restoring lungelastic resistance to elongation, commonly referred to as lung elasticrecoil). This tension, throughout the lung, pulls radially outward onthe airways to hold these airways open and the tension helps to allowair to be squeezed out of the lungs during the expiration breathingcycle. Thus, the tissue gathering element 402 is rotated untilre-tensioning of the lung is achieved to mimic the natural, healthystate of the lung.

In some embodiments, the device 400 is rotationally rigid so thatrotational force that is applied to by the torqueing tool 408 istransmitted directly to the lung tissue. However, in other embodiments,at least a portion of the device 400 is designed to be intentionallyless torque transmissive. This allows the portion to twist more easilyso as to store rotational energy within the structure of the device 400.In some embodiments, the proximal end of the device 400 is rotatable upto 1000 degrees more than the tissue gathering element 402, preferablyup to 720 degrees more than the tissue gathering element 402. In someembodiments, the tissue gathering element 402 and/or other portions ofthe device 400 are torqued sufficiently to be distorted and strained ina way that stores elastic spring energy. By storing this potentialelastic energy using torque forces (e.g. rotation and twisting), theresulting lung tissue tensioning and lung elastic recoil restorationeffects may be prolonged because chronic tensioning force is maintainedon the lung tissue even if continued effects from the disease allow thetissue to elongate over time. As the tissue elongates, portions of thedevice 400 may be allowed to incrementally recover a small amount over atime period of months or years in a rotational recovery or strainrelaxing orientation. However, if sufficient elastic strain energy isstored in the device 400, some residual chronic tension and restorationof lung elastic recoil will be maintained throughout this period andpossibly for the remainder of the patient's lifetime. Thus, the storedelastic strain energy in the device 400 enhances the acute and chronicbenefits to the patient. For example, the stored elastic strain energyprovides chronic tension that is maintained even if the lung tissuecontinues to degrade and elongate. Thus, the stored rotational strainenergy continues to provide benefit to the patient over time as thepatient progresses with complications relating to COPD, even as the lungtissue slowly elongates into the future. In some embodiments, this timeperiod is up to 10 years or up to a lifetime, but even a period of 3years is considered a very acceptable time period.

Once the lung L is desirably re-tensioned, the device 400 is anchored tomaintain the rotated arrangement. This is achieved by deployment of theanchoring element 404. In this embodiment, the anchoring element 404 iscomprised of a shaft 420 which extends from the attachment end 406 inthe same direction as the tissue gathering element 402, generally alonga longitudinal axis 411. Thus, upon deployment, the shaft 420 of theanchoring element 420 bows outwardly, away from the longitudinal axis411 and tissue gathering element 420, such as to form the shape of abifurcation. The anchoring element 404 is then advanced into an adjacentor nearby airway, as illustrated in FIG. 61 . In some embodiments,deployment is achieved by retracting the catheter 430 to expose theanchoring element 404, thereby allowing its deployment. Thus, thecatheter 430 and device 400 are positioned so that such deployment ofthe anchoring element 404 is possible, such as in an airway, proximal toa bifurcation. This may involve pulling the proximal end of the device400 in the proximal direction prior to deployment of the anchoringelement 404. Likewise, in some embodiments, the device 400 is rotated anadditional amount so that the anchoring element 404 is aligned with thedirection that the bifurcation branches off. Visualization may beachieved with a variety of methods, including fluoroscopy and/or imagingthrough the bronchoscope camera. Once desirably positioned, theanchoring element 404 is deployed and advanced into an airway. Forexample, the tissue gathering element 402 resides in a first airwaywhile the anchoring element is deployed and advanced into a secondairway, adjacent or nearby the first airway. The rigidity and robustnessof the airways minimizes or prevents rotation or unwinding of the device400. This is maintained even after the torqueing tool 408 is removed.

The torque that is applied to the lung tissue is a function of thediameter of the distal tissue gathering element 402 or the width of anyshape that is used as the tissue gathering element 402. If the tissuegathering element 402 is less than 0.5 inches wide or in diameter, arange of 0 to 2.0 inch-pounds of torque will be typically applied. Ifthe width or diameter is greater than 0.5 inches, a range of torquebetween 0.3 and 3.0 inch-pounds is typically applied. It is advantageousthat any loss of stored energy due to relaxation of the lung tissueafter removing the torqueing tool 408 will be stored in the lung tissuethrough counter rotation and contact between the anchoring element 404and the adjacent airway or other lung parenchyma or lung structure thatthe anchoring element 404 has been deployed into. As an example, if thetorqueing tool 408, tissue gathering end 402, remainder of device 400and the catheter is rotated 180 degrees in a clockwise direction toapply 1.0 inch ounce of torque to the distal tissue gathering element402, while the remaining portion of the device 400 is still inside thecatheter 430, the torque may be communicated to tissue effectivelythrough portions of the tissue gathering element 402 bearing on thetissue and the tissue may present resistance and a propensity to unwindthe device 400 with an equal amount of torque in the opposite counterclockwise direction. This unwinding may happen if the torqueing tool 408were to be uncoupled and removed. To counter this, the anchoring element404 is deployed and coupled to tissue to prevent this from happening ina gross way. However, after deploying the anchoring element 404, it issimply wedged against the tissue to hold the device fixed with respectto the airway or lung tissue it has been deployed into. The anchoringelement 404 may not have been rotated to rotationally load the anchoringelement 404 against the bifurcation branch or ostium it has been placedinto to resist counter rotation of the device 400, as the torqueing tool408 is removed. Also, the tissue may not have been conditioned to resistrotation such as being loaded in a rotated way to gather loose tissue tocreate rotational resistance. As such, removal of the torqueing tool 408may allow up to 90 degrees of counter-rotation or unwinding of theentire device 400 in a counter clockwise direction until the anchoringelement 404 rotationally loads the lung tissue it has been deployed intoin this same counter clockwise direction. In this example, as much as0.5 inch-pounds of torque may have been lost at the distal end when thetissue gathering element 404 was allowed to unwind 90 degrees in thecounter clockwise direction. However, the tissue anchoring element 404will be rotated 90 degrees in the counter clockwise direction whichloads proximal lung tissue in a rotational direction which improves lungmechanics as previously described herein. The amount of rotational workenergy that is potentially lost at the distal end of the device will begained at the proximal end of the device, as the torqueing tool 408 isremoved. It is possible that the 90 degrees that the tissue anchoringelement 404 is counter rotated may apply as much as 0.5 inch-pounds oftorque to tissue that is adjacent to the proximal end of the device 400and adjacent to the anchoring element 404. The force rotational appliedto tissue by the distal tissue gathering element 402 will be balanced bythe forces that are applied by the anchoring element 404 to rotate theproximal lung tissue. The anchoring element 404 will be anchored intolung tissue that is structurally stiffer than the tissue that the tissuegathering element 402 will be anchored into because lung tissue that iscloser to the trachea is normally reinforced by cartilage. As a result,the rotational torqueing loads that are applied to the tissue may bebalanced but the angle of rotation experienced by the tissue may not bethe same between the two regions of lung tissue.

It may be appreciated that the anchoring element 404 may be deployed toanchor the device 400 in many possible structures of the lung L tomaintain the lung tension but it is often beneficial to deploy theanchoring element 404 in a bifurcation that can be accessed by abronchoscope. This provides support to prevent the continued recovery ofthe tissue gathering element 402 from pulling the device into a moredistal position, over time. By hooking the attachment end 406 of thedevice 400 around the carina of the airway bifurcation, there is strongsupport to keep the device 400 in a position to be later accessed, suchas by using a bronchoscope, to remove the device 400 if the need arises.This is very advantageous to be nearly guaranteed that the implanteddevice 400 can be accessed with a bronchoscope, such with the use of abronchoscope camera alone. This is in contrast to conventional lungvolume reduction coils which tend to migrate so far distally thatbronchoscopes, appropriately sized to guide recapture instrumentation,cannot be advanced far enough and cannot fit in the portion of the lungthat the proximal coil eventually resides within.

In some instances, the device 400 is rotated further in the samedirection that the torqueing tool 408 rotated the device 400 while theanchoring element 404 is being deployed from the bronchoscope 20 ordelivery system catheter 430 or other delivery system component. If theanchoring element 404 is shaped in the form of a helix, removal of theconstraining device, such as by retracting a catheter 430, in theproximal direction will drive rotation of device 400. The direction ofspiral of the helix shape will dictate the direction that the device 400will be rotated. Thus, the helix may be configured to add rotation andtorque in the same direction that the torqueing tool 408 has been usedto rotate device 400 further or the helix may be configured in theopposite direction to remove some rotation or torque to relieve some ofthe torque force during deployment of the anchoring element.

In some instances, the device 400 is pulled proximally (along itslongitudinal axis) to further tension the lung tissue distal to thedevice 400 and/or to position the anchoring element 404 at a moreproximal location. Thus, in some embodiments, the device 400 appliesboth radial re-tensioning within the lung and linear re-tensioningtoward the trachea T. In some embodiments, the proximal pulling of thedevice 400 may be as much as 5 inches, but more preferably it will be0.5 to 3 inches of linear proximal displacement. In these embodiments,the tissue gathering element 402 is strategically positioned within thelung L so that such pulling in the proximal direction is at leastpartially maintained after the anchoring element 404 is deployed so thatthe device 400 applies both radial re-tensioning within the lung andlinear re-tensioning toward the trachea T.

Once desirably positioned and anchored, the device 400 is left in placeas an implant. Thus, the torqueing tool 408 is detached from theattachment end 406 of the device 400 and withdrawn along with thecatheter 430 and bronchoscope 20. Chronic tension is maintained on thetissue to restore lung elastic recoil. In some instances, the patient'sCOPD will progress and the device 400 may gradually unwind, releasingincrements of stored energy, to maintain tensioning of the lung. And, insome advanced cases, the device 400 may ultimately fully untwist so thatthe device 400 has recovered to a zero-strain state due to continuedelongation of tissue because of the progressive nature of the COPDdisease. This can be easily detected, using common medical imagingtechniques, by comparing the rotational position of the tissue gatheringelement 402 relative to the anchoring element 404 to determine if theyare similar to an unconstrained device 400 before it is deployed in thepatient. If the tissue has relaxed sufficiently that the twist in thedevice 400 has been substantially eliminated, additional devices 400 maybe deployed to restore lung function back to the patient or the existingpreviously implanted device 400 may be accessed again with a torqueingsystem that can rotate the device 400 again to energize and restore therotational strain back into the previously implanted device 400.Additionally, the anchoring element 404 may be pulled from its anchoredposition so rotation can be applied and then the anchoring element 404may be advanced back into the same airway branch, a new airway branch orit may be anchored at another anatomical location in the lung to resistunwinding of the device 400.

Medical imaging techniques may be used to visualize device 400 delivery,the deployment of the device 400 from delivery system constraints,rotation or torqueing of device 400, deployment of the anchoring element404, deployment of the tissue gathering element 402, decoupling of thetorqueing tool 408 from the device 400, reattachment of the torqueingtool 408 to device 400, recapture of device 400 by attaching a recapturetool (e.g. a forceps instrument or suture or specialized recapture tooldesigned to couple to a feature of device 400), attaching a guide toolto device 400 to guide a catheter to be advanced to recapture device400, to name a few. Likewise, other maneuvers may be used to visualizeany of the measurable physiologic changes listed herein to improvebreathing in COPD patients during the implantation procedure or afterthe procedure or in comparison to determine change in breathing functionby comparing the physiologic difference in the patient as a result ofplacing one or more device 400 in the patient. Medical imaging may beused to assist in selecting a device 400 size before implantation andany other maneuver that would benefit from visualization whiledelivering device 400, recapturing device 400 or evaluating any of theoutcome parameters. Medical imaging includes the use of all forms ofequipment that allows for real time imaging, recording or computerprocessing that outputs an image of devices, organs or tissue within thehuman body without needing to expose the devices, organs or tissue to bevisualized using a direct line of site by the human eye. These medicalimaging techniques may typically benefit by the emission of low to highfrequency electro-magnetic energy or sound energy which may include theuse of one or more video cameras such as the ones bronchoscopes areequipped with, computed tomography, biplane imaging, fluoroscopy,ultrasound or standard planar x-ray machines.

FIGS. 62A-62D additionally illustrate an embodiment of delivering atorque-based pulmonary treatment device 400. FIG. 62A illustrates thedevice 400 loaded within the catheter 430 which is advanceable through alumen of a delivery device, such as a bronchoscope. Thus, the device 400is constrained within the catheter 430 to allow for ease of movement.The anchoring element 404 and tissue gathering element 402 are drawntogether and the tissue gathering element 402 is uncoiled andstraightened. The device 400 remains within the catheter 430 until thedistal tip of the catheter 430 is desirably positioned within the lungL. In this embodiment, the catheter 430 is then retracted, asillustrated in FIG. 62B, while the torqueing tool 408 remains in place.This exposes the tissue gathering element 402, allowing the element 402to deploy. In this embodiment, the tissue gathering element 402 has acurved shape, particularly an S-shape, wherein a first wing 440 extendsin a first direction (radially outwardly from a longitudinal axis 442 ofthe device 400 and joined torqueing tool 408) and a second wing 444extends in a second direction (radially outwardly from the longitudinalaxis 411). In this embodiment, the first and second directions aredirectly opposite to each other. However, it may be appreciated that thefirst and second directions may be at an angle to each other. Referringto FIG. 62C, the handle 435 is then twisted to rotate the tissuegathering element 402. This causes at least the wings 440, 444 to rotatearound the longitudinal axis 411. This rotation draws the surroundingtissue toward the longitudinal axis 411, as the wings 440, 444 captureand pull the tissue. The tissue gathering element 402 is then anchoredin place by deployment of the anchoring element 404, as illustrated inFIG. 62D. Here, the catheter 430 is further retracted exposing the moreproximally positioned anchoring element 404 which curves or bowsradially outwardly, away from the longitudinal axis 411. As mentioned,in some embodiments, additional torque is applied to the torqueing tool408 in order to align the anchoring element 404 with an available airwaybranch so that the anchoring element 404 is advanceable into the airwaybranch so as to keep the device 400 from unwinding upon release of thetorqueing tool 408. The torqueing tool 408 is then removed from theattachment end 406 and the device 400 is left behind.

A. Tissue Gathering Element

It may be appreciated that the tissue gathering element 402 may becomprised of a variety of materials, may take a variety of forms orshapes, and may include a variety of features.

In some embodiments, device 400 is formed from a single shaft (e.g.wire, cable, braid), wherein the shaft is curved or bent to form thetissue gathering element 402 and an anchoring element 404. In suchembodiments, the attachment end 406 is created by a loop, bend, U shapedbend, coil or other feature of the shaft that allows for grasping orother mechanisms of attachment to a suitable delivery system. Examplesof attachment include attachment to a pusher, grasper, forceps, suture,or catheter, to name a few.

FIGS. 63A-63C illustrate a variety of embodiments of torque-basedpulmonary treatment devices 400. As illustrated, each device 400includes at least one tissue gathering element 402 and at least oneanchoring element 404 which meet at an attachment end 406. More than onetissue gathering elements 402 may be attached to a single device 400 toimprove lung function. More than one anchoring element 404 may beattached to a single device 400 to improve lung function. It may also beappreciated that the embodiments illustrated in FIGS. 63A-63C may beformed from a single shaft to create the tissue gathering element 402and anchoring element 404, as described above, or may be formed frommultiple shafts, etc. It may also be appreciated that the tissuegathering elements 402 may include a distal tip 405, and the tip 405 isoften not the distal-most portion of the tissue gathering element 402.For example, FIGS. 63A-63C illustrate devices 400 having tissuegathering elements 402 comprising a partial loop which curves radiallyoutwardly from the longitudinal axis 411. In some embodiments, the loopextends such that the distal tip 405 is directed back toward thelongitudinal axis 411 (e.g. FIG. 63A-63B). In other embodiments, thedistal tip 405 is directed substantially parallel to the longitudinalaxis 411 in the distal direction, such as extending around a full circle(e.g. FIG. 63C). In such embodiments, the tissue gathering element 402may be described as having a radius R. As the radius R of the tissuegathering end is increased, the circumference of the loop is increasedby a factor of 2π (i.e. 2×3.1415). Thus, increasing the size of the loopincreases the volume of tissue that can be gathered, particularly by πR²(i.e. the area of a circle; the square of R times 3.1415). In someinstances, it is desirable for the loop to extend as far as feasiblypossible to create a maximum radius to increase effectiveness ingathering tissue. Such feasibility depends on a variety of factors,including shaft construction, loop design, and desired function, to namea few. In some instances, it is desired that the loop has increasedtorsional strength so as to more efficiently gather tissue.

In other embodiments, the tissue gathering element 402 may not becircular so the effective dimension may be described as having a widthW. Looking at FIG. 63A, if the tissue gathering element 402 was notcircular, what is shown as R would be described as W. Stated anotherway, W is the extreme maximum width of a non-circular tissue gatheringelement shape. As the width W of the tissue gathering element 402 isincreased, the path length around the tissue gathering element 402 isincreased by a factor of 2×W to describe the length of lung tissue thatis pulled towards the longitudinal axis 411 by rotating the tissuegathering element 360 degrees. Thus, increasing the width W of thetissue gathering element 402 increases the length of tissue that can begathered, particularly by 2 times the width W. In some instances, it isdesirable for the tissue gathering element 402 width W to extend as faras feasibly possible to create a maximum width to increase effectivenessin gathering tissue. Such feasibility depends on a variety of factors,including shaft construction, tissue gathering element 402 design, anddesired function, to name a few. In some instances, it is desired thatthe loop has increased torsional strength so as to more efficientlygather tissue. The tissue gathering width W may be produced in a rangebetween 0.25 and 3 inches but a range between 0.5 and 1.0 inches ispreferable. If ribbon is used to make the tissue gathering element 402,it's preferable to use ribbon between 0.005 and 0.030 inches thick ifit's made from metallic material. The width of the ribbon is typicallybetween 0.005 and 0.100 inches but preferably between 0.040 and 0.075inches wide to withstand the torqueing forces and to resist deforming tosuch a degree that it no longer effectively gathers tissue.

In some embodiments, the loop shape is designed to increase strengthduring torsion. For example, in some embodiments, the loop has a “D” or“P” shape wherein the loop extends over the longitudinal axis 411,crossing the portion of the tissue gathering element 402 that extendsalong the longitudinal axis 411 (e.g. FIG. 64 ). By forming a shape inthe shaft 412 that crosses over itself, the circular section of the “D”or “P” shape or other looping shape is stiffened to resist twist ortorsional deformation. Stiffening is provided because the free end(distal tip 405) is stabilized at the crossing point, against theportion of the shaft that it crosses. These crossing points or points ofcontact may optionally be held together with a reinforcing element, suchas a crimped tube connector, or they may be joined together, such as bybrazing or welding (e.g. with an arc or using laser light or anycombination), to geometrically stiffen the attachment end 406, theanchoring element 404 or the tissue gathering element 402.

When rotating the tissue gathering element 402 around the longitudinalaxis 411 the direction of the cross-over, so that the tissue presses theshaft 412 against itself at the cross-over point, the cross-over resistsdeformation of the loop. By arresting the deformation in this way, thelooped portion of the tissue gathering element 402 is made moreeffective to transmit torque or rotation energy directly to the tissue.When rotating the tissue gathering element 402 in the oppositedirection, the tissue gathering element 402 will deform because the freedistal tip 405 is not supported to prevent the deformation. In someinstances, this may be beneficial because the deformation stores elasticstrain energy in the device 400 that can continue to perform work on thelung L after the delivery system has been removed (like loading a springand leaving it in the body to continue pulling on tissue).

It may be appreciated that the distal tip 405 may have a variety offorms. In some embodiments, the distal tip 405 is atraumatic and has ablunt shape, such as a ball or other rounded shape (e.g. FIG. 63A). Inthis configuration, the tissue gathering element 402 may be moreinclined to track along the inside lumen of an airway if the airways arestill preserved. However, in nearly all cases, they are not. If thedistal tip includes a ball that is smaller than 0.060 inches diameter,it will still be capable of penetrating the wall of an airway to engageconnective alveoli instead of manipulating airways alone. In otherembodiments, the distal tip 405 has a sharp shape, configured to pierceand/or penetrate tissue (e.g. FIG. 63B). In other embodiments, thedistal tip 405 has an anchoring shape, such as a fish-hook or othershape which is configured for piercing or penetrating tissue whileresisting withdrawal from the tissue (FIG. 63C).

In some embodiments, the device 400 is made from round wire. It may beappreciated that in some embodiments the round wire has been flattenedat the distal tip or any other portion of the tissue gathering element402 to add bearing area. For example, FIG. 65 illustrates an embodimentof a device 400 formed from flattened wire. In this embodiment, thetissue gathering element 402 is formed from a shaft 412 and theanchoring element 404 is formed from a shaft 420, wherein the shafts412, 420 are fixed together to form the attachment end 406. Each shaft412, 420 has a flattened, broader surface, such as a ribbon, wherein theflattened surfaces are mated so as to increase contact for fixing toeach other. Fixing the elements together may be accomplished by welding,gluing, thermally friction bonding, crimping, locking together usingpuzzle lock patterns, locking extrusion sections within each other,wrapping with a spring, riveting, locking together with threadedfasteners, by joining using locking hardware that is known in the art.In some embodiments, the flattened or broader surface is arranged to beperpendicular to the direction the shaft 412 contacts tissue to preventthe tissue gathering element 402 from cutting or migrating throughtissue over time. Thus, the flattened or broader surface serves as thebearing area. In some instances, this is particularly useful alongcurved portions of the tissue gathering element 402 so as to prevent thecurved portion of the tissue gathering element 402 from cutting ormigrating through tissue over time.

FIG. 66 illustrates an embodiment of a device 400 formed from oval wire.In this embodiment, the tissue gathering element 402 is formed from ashaft 412 and the anchoring element 404 is formed from a shaft 420,wherein the shafts 412, 420 are fixed together with the use of anattachment element 410. The attachment element 410 assists in joiningthe shafts 412, 420 and forming a desired shape for attachment andtorqueing. In this embodiment, the broader side of the oval wire isarranged to be perpendicular to the direction the shaft 412 contactstissue to prevent the tissue gathering element 402 from cutting ormigrating through tissue over time.

FIGS. 65-66 also illustrate tissue gathering elements 402 having a shapewhich is more similar to an arc or arch than a loop. In FIG. 65 , theshaft 412 bends radially outwardly from the longitudinal axis 411 toform a curved arch wherein the distal tip 405 is parallel to thelongitudinal axis 411 facing the proximal direction. In FIG. 66 , theshaft 412 bends radially outwardly from the longitudinal axis 411 toform a curved arc wherein the distal tip 405 parallel to thelongitudinal axis 411 facing the radially outwardly from thelongitudinal axis 411.

It may be appreciated that the tissue gathering element 402 may haveirregular shapes or compound curvatures. For example, FIG. 67illustrates a tissue gathering element 402 having a shape formed by theshaft 412 curving radially outwardly from the longitudinal axis 411 andforming a first curvature 450, a second curvature 452 and then a thirdcurvature 454. The first curvature 450 has an arc shape which thentransitions into an inverse arc shape for the second curvature 452. Thisthen transitions into a semi-circle or arch shape which directs thedistal tip 405 toward the longitudinal axis 411. This compound curvature(combination of curvatures 450, 452, 454) creates a hook shape which maybe particularly beneficial for gathering tissue in both a twistingfashion and a pulling fashion. The partial loop shape extending radiallyoutwardly from the longitudinal axis 411 assists in gathering tissueduring torqueing, as described above. And, the hooking shape (distal tip405 facing the longitudinal axis 411) assists in holding the tissue whenpulling the device 400 in the proximal direction, such as along thelongitudinal axis 411.

It may also be appreciated that the tissue gathering element 402 mayhave a variety of other shapes, including bends and arcs which arerounded or angular, in the same direction or opposite directions, and ina variety of configurations. FIG. 68 illustrates a tissue gatheringelement 402 similar to that illustrated in FIGS. 62A-62D. In thisembodiment, the tissue gathering element 402 has a curved shape,particularly an S-shape, wherein a first wing 440 extends in a firstdirection (radially outwardly from a longitudinal axis 411) and a secondwing 444 extends in a second direction (radially outwardly from thelongitudinal axis 411). In this embodiment, the first and seconddirections are directly opposite to each other. However, it may beappreciated that the first and second directions may be at an angle toeach other. In addition, this embodiment illustrates the distal tip 405aligned with the longitudinal axis 411, particularly facing in thedistal direction.

It may be appreciated that the shaft 412 may include various additionalbends or curvatures to provide particular features. For example, FIG. 69illustrates an embodiment wherein the shaft 412 is configured to providestrain relief. Here, the shaft 412 has one or more bends, switchbacks orwings in succession configured to act as a strain relief whilemanipulating the device 400. In this embodiment, the strain reliefportion 460 is disposed proximal to the tissue gathering end 404. Thus,pulling in the proximal direction, such as along the longitudinal axis411, would expand the strain relief portion 460 leaving the tissuegathering end 404 in position. This may be desired in situations whereinit is preferred to maintain position of the tissue gathering end 404when pulling the attachment end 406, such as when positioning theanchoring element 404.

It may be appreciated the shaft 412 of the tissue gathering end 404 mayvary in terms of construction and materials so as to provide variousfeatures. In some embodiments, as illustrated in FIGS. 70A-70B, theshaft 412 is comprised of a tube 461 having slots or cuts 462 along atleast a portion of its length. Such cuts 462 may be fabricated by lasercutting of the tube 461. In addition, a pull cord 464 is positionedwithin or along the tube 461 extending distal to the cuts 462. The cuts462 are aligned along the tube 461 so as to allow flexibility of thetube 461 while the pull cord 464 is slack (FIG. 70A), and to allowcurvature along a predetermined arc or arch when the pull cord 464 ispulled (FIG. 70B). Such pulling closes the slots or cuts 462, holdingthe shaft 412 in the curved formation. This construction providesincreased torque strength and allows the tissue gathering end 404 totransmit higher levels of torque. It may be appreciated that althoughthe shaft 412 is illustrated with a needle tip, any suitable tip shapemay be used.

In other embodiments, the shaft 412 is comprised of a twisted pair ofwires or a combination of more than 2 wires. In other embodiments, theshaft may be pressure cast or made from powder metal to form a near netshape that varies in dimension along its length. Near net shapes arelimited only to the shape of a mold that is used to forge the powdermetal together to form a high performance metalized composite materialof nearly any shape. In another embodiment, the shaft 412 is made from atwisted pair of wires, the preferable direction of rotation that theuser should use to rotate the tissue gathering element 402 within thelung is the same direction that was used to produce the twist in thetwisted pair of wires. This same direction will further tighten thetwist to maintain a reasonably small diameter of the tissue gatheringelement 402. This will also transmit the greatest amount of torquethrough the delivery system and the device 400 to the tissue. This isthe direction that will transmit the maximum torque force to the lungtissue.

In some embodiments, the tissue gathering element 402 comprises a jacketwhich extends over at least a portion of the shaft 412 so as to increasegripping of the lung tissue and reduce cutting through lung tissue (i.e.“cheese wiring”). FIGS. 71A-71C illustrate example embodiments ofjackets 470. FIG. 71A illustrates a jacket 470 comprising a coil 472which extends over a portion of the shaft 412 to increase bearing areaon the tissue. In some embodiments, the coil 472 comprises a spring coilthat is tight wound to grip the shaft 412. In some embodiments, gapsbetween coil turns are spaced between 0.003 and 0.100 inches so as toincrease friction between the tissue gathering element 402 and thetissue, therefore enhancing tissue gathering. In some embodiments, asuitable coil 472 outer diameter would be larger than 0.018″ and smallerthan 0.130″ to be suitable to fit in a typical bronchoscope. FIG. 71Billustrates a jacket 470 comprising a flexible sleeve 474. In someembodiments, the flexible sleeve 474 comprises a woven material, such asDacron or polyester. In other embodiments, the flexible sleeve 474comprises a braided tube. In either case, the flexible sleeve 474increases bearing area on the tissue and increases friction or gripping.In other embodiments, the flexible sleeve 474 comprises silicone. Inother embodiments, the flexible sleeve 474 comprises shrink fit tubing.FIG. 71C illustrates a jacket 470 comprising a combination of a coil 472and a sleeve 474. In this embodiment, the coil 472 extends over theshaft 412 and the sleeve 474 extends over the coil 472. Thus, the jacket470 may be comprised of a coil 472 having shrink fit tubing thereover.

In some embodiments, the distal tip of the tissue gathering element 402comprises a balloon expandable or self-expanding stent structure thatgrips an airway wall or that grips to lung tissue as the stent isdilated to minimize the distal tip from being pulled out of the tissueas the device 400 is rotated, to further increase the effectiveness ofthe tissue gathering.

B. Anchoring Element

It may be appreciated that the anchoring element 404 may be comprised ofa variety of materials, may take a variety of forms or shapes, and mayinclude a variety of features.

As mentioned previously, in some embodiments, the device 400 is formedfrom a single shaft (e.g. wire, ribbon, cable, braid), wherein the shaftis curved or bent to form the tissue gathering element 402 and theanchoring element 404. In such embodiments, the attachment end 406 iscreated by a loop, bend, U shaped bend, coil or other feature of theshaft that allows for grasping or other mechanisms of attachment to asuitable delivery system. Examples of attachment include attachment to apusher, grasper, forceps, suture, or catheter, to name a few.

As mentioned previously, FIGS. 63A-63C illustrate a variety ofembodiments of torque-based pulmonary treatment devices 400. Asillustrated, each device 400 includes a tissue gathering element 402 andan anchoring element 404 which meet at an attachment end 406. It may beappreciated that the embodiments illustrated in FIGS. 63A-63C may beformed from a single shaft to create the tissue gathering element 402and anchoring element 404 or may be formed from multiple shafts, etc. Asshown in these embodiments, the anchoring element 404 is typicallycomprised of a shaft 420 which extends from the attachment end 406 inthe same direction as the tissue gathering element 402, generally alonga longitudinal axis 411. Thus, upon deployment, the shaft 420 of theanchoring element 420 bows outwardly, away from the longitudinal axis411 and tissue gathering element 420, such as to form the shape of abifurcation. The anchoring element 404 is then advanced into an adjacentor nearby airway to anchor the device 400.

FIG. 63A illustrates an anchoring element 404 comprising a loop whichcurves radially outwardly from the longitudinal axis 411. In someembodiments, the loop extends such that its distal tip 407 is directedback toward the longitudinal axis 411. In some embodiments, the distaltip 405 is directed so that the loop extends substantially around a fullcircle. In such embodiments, the anchoring element 404 may be describedas having a radius R. Increasing R increases the moment on fixing theproximal end of the device 400. Torque resistance=R×F (friction in thetissue). By increasing R, less friction is needed to hold the device 400from counter rotating. Some embodiments may include barbs or hooks thatpenetrate the airway wall and increase the R dimension to reinforceanchoring and resistance to counter rotating with respect to thetorqueing force that had been applied to the tissue gathering element402 and tissue.

FIG. 63B illustrates an anchoring element 404 which bows radiallyoutwardly away from the longitudinal axis 411 and then curves backtoward the longitudinal axis 411 and extends along the longitudinal axis411 in the distal direction. In this embodiment, the proximal end of thetissue gathering element 402 similarly bows radially outwardly from thelongitudinal axis 411, substantially symmetrical to the anchoringelement 404.

FIG. 63C illustrates a plurality of anchoring elements 404 on a singledevice 400. In this embodiment, three anchoring elements 404 extend fromthe attachment end 406, however any number may be present including one,two, three, four, five, or more. In this embodiment, each anchoringelement 404 extends in a different radial direction from thelongitudinal axis. This provides the user with a variety of options whenanchoring the device 400. In particular, the anchoring element 404 mostsuitably positioned for anchoring within the particular anatomy may beused to anchor the device 400. Or, more than one anchoring element 404may be used in the same or differing airways for additional anchoringsupport.

It may be appreciated that in some embodiments, such as illustrated inFIGS. 65-66 , the anchoring element 404 has a shape which is moresimilar to an arc or arch than a loop. In FIG. 65 , the shaft 420 bendsradially outwardly from the longitudinal axis 411 to form a curved archwherein the distal tip 407 is parallel to the longitudinal axis 411facing the proximal direction. In FIG. 66 , the shaft 420 bends radiallyoutwardly from the longitudinal axis 411 to form a curved arc whereinthe distal tip 407 parallel to the longitudinal axis 411 facing theradially outwardly from the longitudinal axis 411.

It may also be appreciated that the anchoring element 404 may have avariety of other shapes, including bends and arcs which are rounded orangular, in the same direction or opposite directions, and in a varietyof configurations. FIG. 68 illustrates an anchoring element 404 having acurved shape, particularly an S-shape, wherein a first wing 441 extendsin a first direction (radially outwardly from a longitudinal axis 411)and a second wing 445 extends in a second direction (radially outwardlyfrom the longitudinal axis 411). In this embodiment, the first andsecond directions are directly opposite to each other. However, it maybe appreciated that the first and second directions may be at an angleto each other. In addition, this embodiment illustrates the distal tip407 aligned with the longitudinal axis 411, particularly facing in thedistal direction.

It may be appreciated that in any of the embodiments, the tissuegathering element 402 and anchoring element 404 may extend radiallyoutwardly from the longitudinal axis 411 in the same or differentdirections. Likewise, it may be appreciated that in any of theembodiments, the tissue gathering element 402 and anchoring element 404may have the same or similar shapes or different shapes.

It may be appreciated that in some embodiments the anchoring element 404maintains position in an airway or area of the lung anatomy by simpleentrapment of the anchoring element 404, such as insertion into anairway that is separate from the pathway to the tissue gathering element402. In such instances, the anchoring element 404 may be “loose” withinthe airway yet pressed against a portion of the airway due to forcesapplied via the attachment end 406 so as to anchor the device 400. Suchanchoring elements 404 may be easily removable by releasing the forcesapplied via the attachment end 406 or applying sufficient pulling forcein the proximal direction. In other embodiments, the anchoring element404 is actively anchored within the airway so as to maintain anchoringwithout relying on forces applied via the attachment end 406 foranchoring. FIG. 72 illustrates an embodiment of an anchoring element 404comprising an expandable basket 480. In this embodiment, the expandablebasket 480 is insertable into an airway or other anatomy and expandableso as to apply radial outward force upon the airway. This holds thebasket 480 within the airway resisting movement within the airway. This,in turn, anchors the device 400 and holds the tissue gathering element402 in place. FIG. 73 illustrates an embodiment of an anchoring element404 comprising one or more anchoring hooks 486. In this embodiment, theone or more anchoring hooks 486 are insertable into an airway or otheranatomy and expandable so as to puncture or penetrate the wall of theairway. This holds the one or more anchoring hooks 486 within the airwayresisting movement within the airway. This, in turn, anchors the device400 and holds the tissue gathering element 402 in place. FIG. 74illustrates an embodiment of an anchoring element 404 comprising anexpandable stent 490. The stent 490 may be comprised of a variety ofmaterials, such as nitinol, steel, etc. Likewise, the stent 490 may bebraided or laser cut, to name a few. In this embodiment, the expandablestent 490 is insertable into an airway or other anatomy (such as aloneor with the use of a guidewire) and expandable so as tocircumferentially expand against the inner walls of the airway. In someembodiments, the stent 490 is self-expanding and in other embodimentsthe stent 490 is expandable with assistance, such as by ballooninflation. This holds the stent 490 within the airway resisting movementwithin the airway. This, in turn, anchors the device 400 and holds thetissue gathering element 402 in place.

C. Attachment End

As mentioned previously, the torque-based pulmonary treatment device 400typically comprises an attachment end 406 where the tissue gatheringelement 402 and an anchoring element 404 join. The attachment end 406may be used to attach a delivery device thereto, such as a torqueingtool 408. Thus, the attachment end 406 typically has a non-roundcross-section shape, such as a square, rectangular, polygonal or ovalshape, to assist in maintaining rotational toque coupling and torquetransmission during rotational or torqueing motion of the torqueing tool408. It may be appreciated that in some embodiments the attachment end406 is formed from portions of the tissue gathering element 402 andanchoring element 404 themselves, such the joining of their respectiveproximal ends. In other embodiments, the tissue gathering element 402and anchoring element 404 are formed from a continuous shaft and theattachment end 406 is formed from a bend or crimp in the shafttherebetween. In some embodiments, the attachment end 406 includes anattachment element 410 to assist in joining and/or holding the elements402, 404 and forming a desired shape for attachment and torqueing. Andyet in other embodiments, the attachment end 406 resides at the proximalend of the tissue gathering element 402 or the anchoring element 404 andthe elements 402, 404 are joined to each other distally of theattachment end 406.

As mentioned, in some embodiments, the attachment end 406 is formed fromportions of the tissue gathering element 402 and anchoring element 404themselves, such the joining of their respective proximal ends. FIG. 75illustrates such an embodiment wherein the proximal ends of the tissuegathering element 402 and anchoring element 404 are bonded together bygluing or welding but they may also be joined by riveting, usingthreaded fasteners, crimping using a tubing or spring coupler, press fittogether using a coupler or interlocking features such as threading ahitch pin, it may also be sutured together or tied using metal orplastic wire, cable, fibers, string, or they may be fused together bycongealing biologic material they may be held adjacent to each otherusing magnetic attraction force with magnetic materials. Thus, FIG. 75illustrates bonding material 510 between and optionally covering outerportions of the tissue gathering element 402 and anchoring element 404.

As mentioned, in some embodiments, the tissue gathering element 402 andanchoring element 404 are formed from a continuous shaft 412 and theattachment end 406 is formed from a bend or crimp in the shafttherebetween. FIG. 76A illustrates such an embodiment wherein theattachment end 406 has the form of a bend, in particular a loop-shapedbend. FIG. 76B illustrates an example of usage of the embodiment of FIG.76A. Here, the attachment end 406 is connected with another device, suchas a torqueing tool 408 or removal tool, using a hitch pin 503 with aball end 505. The hitch pin 503 releasably attaches the devicestogether. Removal of the hitch pin 503 detaches the devices from eachother. It may be appreciated that this design may also be used to pinthe tissue gathering element 402 and the anchor element 404 together.

FIG. 77 illustrates a portion of an attachment end 406 of a device 400having torqueing tool socket 507 that has been slipped thereover. Thetorqueing tool socket 507 has a shape that allows for a slip fit overthe portion of the attachment end 406. The socket 507 is attached to orpart of a torqueing tool 408 so that rotation of the torqueing tool 408is transmitted through the torqueing tool socket 507 and translated tothe attachment end 406. Likewise, the torqueing tool 408 is able to betranslated longitudinally to be released from the device 400 withoutrequiring any actuation of any mechanism to release the slip fitconnection.

In some embodiments, the attachment end 406 is configured to mate with atorqueing tool 408 in a manner which temporarily locks the device 400and tool 408 together. In some instances, this assists in positioningthe device 400 wherein the device 400 can be easily advanced andretracted with the use of the tool 408. For example, in FIG. 78 theattachment end 406 has a threaded outer surface and the torqueing tool408 includes threaded inner surface. This allows the attachment end 406to join with a torqueing tool 408 in a screw-type manner. In thisembodiment, the torqueing tool 408 has a threaded receptacle 550configured to receive the attachment end 406 so as to mate the threadingsurfaces together. It may be appreciated that such joining may beachieved by rotation of the torqueing tool 408, wherein continuedrotation in the same direction then rotates or torques the tissuegathering element 402. Once desired rotation has been achieved, theanchoring element 404 is actuated and the torqueing tool 408 is thenunscrewed from the attachment end 406. FIG. 79 illustrates an attachmentend 406 which keys into the torqueing tool 408. In this embodiment, theattachment end 406 includes an extension 570 which extends away from thelongitudinal axis 411 of the device 400. The extension 570 may have anysuitable shape including a rod, protrusion, bump, etc. In thisembodiment, the torqueing tool 408 includes a receptacle 580 having agroove or cutaway 582 configured to receive the extension 570 uponmating of the attachment end 406 with the receptacle 580. Typically, thecutaway 582 extends along a first direction, such as along thelongitudinal axis 411 and then extends along a second direction, such asangular or perpendicular to the longitudinal axis 411. As the attachmentend 406 is joined with the torqueing tool 408, the extension 570 isadvanced along the cutaway 582 (along the first and second directions)which typically involves rotating the torqueing tool 408 to allowadvancement of the extension along the second direction. Positioning ofthe extension 570 within the cutaway 582 along the second directiontemporarily locks the attachment end 406 to the torqueing tool 408during pulling or pushing along the longitudinal axis 411. It may beappreciated that continued rotation of the torqueing tool 408 in thesame direction rotates or torques the device 400. since the extension570 is unable to slide out of the cutaway 582. Once desired rotation hasbeen achieved, the anchoring element 404 is actuated and the torqueingtool 408 is then rotated in the reverse direction to release theextension 570 from the receptacle 580.

In other embodiments, the attachment end 406 includes one or moreaccessories configured to assist in rotation of the device 400. Forexample, FIG. 80 illustrates an embodiment of an attachment end 406having at least one protrusion 590 which extends radially outwardly fromthe longitudinal axis 411. The at least one protrusion 590 provides alarger surface area for attachment to the torqueing tool 408. In thisembodiment, the torqueing tool 408 comprises a grasper which grasps theat least one protrusion 590. Rotation of the torqueing tool 408 thusrotates the device 400. The torqueing tool 408 is then disengaged fromthe device 400 by releasing the grasper.

In some embodiments, the anchoring element 404 is positionable withinthe same airway or passageway as the tissue gathering element 402 orwithin an airway or passageway which is proximal to that of the tissuegathering element 402. FIG. 81 illustrates an embodiment of such adevice 400. Here, the anchoring element 404 is disposed in the oppositedirection as the tissue gathering element 402, along the longitudinalaxis 411. Here, the anchoring element 404 comprises an expandable stent490. Thus, the tissue gathering element 402 may be advanced into anairway and desirably positioned. The device 400 is then anchored inplace by expanding the stent 490 proximally of the tissue gatheringelement 402. This may be particularly useful in situations wherein anearby airway is not available for anchoring due to anatomicalconfiguration or lack of strength.

FIGS. 82A-82B illustrate another embodiment wherein the anchoringelement 404 is positionable within the same airway or passageway as thetissue gathering element 402. Here, the anchoring element 404 isdisposed in the opposite direction as the tissue gathering element 402,along the longitudinal axis 411. Here, the anchoring element 404comprises a coil 491. Thus, the tissue gathering element 402 may beadvanced into an airway or through the wall of the airway into destroyedfragile lung tissue and desirably positioned. The device 400 is thenanchored in place by deploying the coil 491 which expands within aluminal passageway or airway proximally of the tissue gathering element402. In this embodiment, the device 400 includes an attachment feature610 near the proximal end of the coil 491 and an additional attachmentfeature 610′ disposed between the tissue gathering element 402 and theanchoring element 404. Thus, the torqueing tool 408 may be attached toeither attachment feature 610, 610′ for the most desirable outcome.Alternatively, more than one torqueing tool 408 may be attached todevice 400 to apply torque and to help deploy the anchoring element 404.One or both of the torqueing tools may also be used to remove the device400 from the lung in a coordinated way if this is desirable. FIG. 82Billustrates the device 400 of FIG. 82A rotated 90 degrees about thelongitudinal axis 411. In this embodiment, the tissue gathering element402 has a hook or loop shape. It may be appreciated that the loop of thetissue gathering element 402 may curve within a single plane. However,in this embodiment, the loop of the tissue gathering element 402 curveswithin multiple planes, as illustrated in FIG. 82B. This may bebeneficial when the tissue gathering element 402 is less rigid andtherefore less capable of moving tissue. The out-of-plane curvatureaccounts for such flexibility wherein rotation of the tissue gatheringelement 402 causes the tissue to align the loop toward a single plane.The tissue gathering element 402 then has increased ability to movetissue.

FIG. 82C illustrates another embodiment of a pulmonary treatment device400 having a tissue gathering element 402 and an anchoring element 404.In this embodiment, the device 400 is formed from a continuous shaft 412which bends to form the elements 402, 404. Here, the device 400generally extends along a longitudinal axis 411. The tissue gatheringelement 402 is formed by the shaft 412 bending radially outwardly awayfrom the longitudinal axis 411 forming a loop around an axis 413 that isperpendicular to the longitudinal axis 411. In some embodiments, theouter diameter of the loop that is formed around the axis 413 in therange of 0.400 inches to 3.0 inches in diameter or any size between.Most preferably, the loop may have an outer diameter in the range of0.75 inches and 1.25 inches. In this embodiment, the loop continues intoa full loop shape around the axis 413, however it may be appreciatedthat in other embodiments the loop is a partial loop forming an arcshape. In this embodiment, the anchoring element 404 is formed by theshaft 412 bending into a coiled shape, wherein each turn of the coilextends at least partially around the longitudinal axis 411. In thisembodiment, the shaft 412 has a flattened, ribbon shape. In someembodiments, the ribbon shape is between 0.005 and 0.030 inches wide andbetween 0.005 and 0.030 inches thick in dimension. The ribbon may beblasted or tumbled in abrasive media to round the edges so it moreclosely appears like a round cross-section wire. Alternatively, theanchoring element 404 may be made from round cross section wire, forexample having a diameter between 0.003 and 0.050 inches. The coiledshape may be configured to form a coil shaped stent or helix with anouter diameter of the helix that is between 5 mm and 17 mm in diameterbut more preferably it is between 6 mm and 10 mm in diameter. Thus, thetissue gathering element 402 has a stiffness sufficient to move lungtissue, particularly to move lung tissue around the longitudinal axis411. Thus, in such a situation the longitudinal axis 411 becomes arotational axis.

FIG. 82D illustrates another embodiment of a pulmonary treatment device400 having a tissue gathering element 402 and an anchoring element 404.In this embodiment, the device 400 is formed from a continuous shaft 412which bends to form the elements 402, 404 in a shape similar to that ofFIG. 82C. Likewise, the tissue gathering element 402 has a flattened,ribbon shape. However, in this embodiment, the ribbon is twisted alongits length in at least one location 415 so as to rotate at least oneportion of a flat surface of the ribbon 417 toward an edge of theribbon, as shown. In particular, the ribbon is twisted along its lengthat multiple locations 415 so as to rotate a series of portions of theflat surface 417 of the ribbon toward the edge of the ribbon. Thus, whenthe device 400 is rotated about the longitudinal axis 411, the series ofportions of the flat surface of the ribbon are posed to engage thesurrounding tissue. This adds 300-500% more bearing area against thetissue for engagement. This reduces the stress on the tissue to lessthan 20% compared to when the edge of the ribbon engages the tissue.

It may be appreciated that the anchoring elements 404 described hereinmay be positioned within an airway, lung passageway, blood vessel,parenchyma, or destroyed tissue, to name a few. The choice of designused for the anchoring element 404 is typically chosen based on theanatomy or environment within which the element 404 is to be positioned.For example, a stent 490 design may be more suitable for a luminalpassageway while an anchoring hook 486 design may be more suitable fordamaged tissue.

FIGS. 82E-82G illustrate steps in an example method of deploying atorque-based pulmonary treatment device 400 such as illustrated in FIGS.82A-82D. In this embodiment, deployment begins (FIG. 82E) by pushing thedevice 400 through a catheter 430 and out its distal end so that thetissue gathering element 402 extends from the distal end of the catheter430 and curves radially outwardly from the longitudinal axis 411. As thetissue gathering element 402 is further advanced additional portions ofthe tissue gathering element 402 extend from the distal end of thecatheter 430, curving around into a loop shape, as shown. FIG. 83Fillustrates rotation of the device 400, such as by rotation of thecatheter 430 around the longitudinal axis 411. The forces on the tissueadjacent the tissue gathering element 402 move the tissue around thelongitudinal axis 411 into a torqued configuration. This tensions thesurrounding tissue. Once the lung has been desirably tensioned, thedevice 400 is then anchored to maintain the tensioning or resistunwinding of the device from the torqued configuration. In thisembodiment, this is achieved by deploying the anchoring element 404, asillustrated in FIG. 82G. In this embodiment, the anchoring element 404had a coil shape and is concentrically aligned with the longitudinalaxis 411. In this embodiment, deployment of the anchoring element 404 isachieved by retracting the catheter 430 so as to allow the coils of theanchoring element 404 to expand. In this embodiment, a torqueing tool108 remains attached to the device 400 at this stage of delivery. Thetorqueing tool 408 is then removed from the device 400. The device 400is then left in place as an implant while the catheter 430 is removed.

FIGS. 83A-83J provide a more detailed illustration of steps in anexample method of deploying a torque-based pulmonary treatment device400 such as illustrated in FIGS. 82A-82D. To begin (FIG. 83A), thedevice 400 is loaded within a catheter 430 or similar delivery devicewhich is configured to be advanceable through a lumen in an endoscope,such as a bronchoscope 20. The device 400 is constrained within thecatheter 430 (along longitudinal axis 411) to allow for ease ofplacement. The device 400 is attached to a torqueing tool 408 whichextends from the distal end of the catheter 430. In this embodiment, thetorqueing tool 408 includes a handle 435. In this embodiment, deploymentbegins by advancing the torqueing tool 408 into the catheter 430 so asto begin pushing the device 400 through the catheter 430 and out itsdistal end. FIG. 83A illustrates the distal tip 405 of the tissuegathering element 402 extending from the distal end of the catheter 430along the longitudinal axis 411. As the torqueing tool 408 isadditionally advanced, as illustrated in FIG. 83B, additional portionsof the tissue gathering element 402 extend from the distal end of thecatheter 430. Due to pre-curves set into the tissue gathering element402 the distal tip 405 begins curving radially outwardly from thelongitudinal axis 411. As the torqueing tool 408 is yet furtheradvanced, as illustrated in FIG. 83C, additional portions of the tissuegathering element 402 extend from the distal end of the catheter 430,curving around into a loop shape. Here, the distal tip 405 is directedtoward a sample tissue area 600 located off-set from the longitudinalaxis 411. The sample tissue area 600 is demarked to illustrate how thesample tissue area 600 may move in response to torqueing the device 400.However, it may be appreciated that a larger mass of tissue surroundingthe sample tissue area 600 is moved by rotation of the device 400.

FIG. 83D illustrates the start of rotating the torqueing tool 408; asindicated by arrow 602, the torqueing tool 408 is rotated in thecounter-clockwise direction in this embodiment. It may be appreciatedthat in other embodiments, the torqueing tool 408 may be rotated in theclockwise direction. In this embodiment, slight resistance of the tissueis illustrated wherein the torqueing tool 408 rotates while the tissuegathering element 402 flexes. The forces on the sample tissue area 600begin to pull the surrounding tissue creating tension, as illustrated byarrow 604. FIG. 83E illustrates further rotation of the torqueing tool408. At this point the curved portion of the tissue gathering element402 has rotated around the longitudinal axis 411 pulling the sampletissue area 600 along with it. This further tensions the surroundingtissue as illustrated by arrow 606. Additionally, in this embodiment,the torqueing tool 408 is pulled back, in the proximal direction alongthe longitudinal axis 411, as indicated by arrow 608. This additionallyapplies longitudinal force to the sample tissue area 600 as indicated byarrow 611. As illustrated in FIG. 83F, the torqueing tool 408 is thenretracted further in this embodiment, as illustrated by arrow 608.Because the tissue gathering element 402 has been distorted due to therotational and longitudinal motions illustrated in FIG. 83E, the tissuegathering element 402 has been interlocked into tissue to allowadditional rotation and translation motions and applied forces to tissuethat would not normally have been possible without pulling the tissuegathering element 402 out of tissue. Designing the tissue gatheringelement in a way that allows it to be rotated and translated so it isdistorted to converge more closely to occupy a plane that isperpendicular to axis 411 locks it into tissue to allow more extremetorsion and translational forces to be applied to tissue. In thisembodiment, the device 400 is then additionally rotated, as illustratedin FIG. 83G, so as to further wrap the surrounding tissue around thetissue gathering element 402. Thus, the sample tissue area 600 continuesrotating around the longitudinal axis 411, applying further radial andlongitudinal tension on the surrounding lung. Once the lung has beendesirably tensioned, the device 400 is then anchored to maintain thetensioning. In this embodiment, this is achieved by deploying theanchoring element 404. In this embodiment, the anchoring element 404 hada coil shape and is concentrically aligned with the longitudinal axis411. FIG. 83H illustrates deployment of the anchoring element 404wherein the catheter 430 is retracted to allow the coils of theanchoring element 404 to expand. In this embodiment, the torqueing tool108 remains attached to the device 400 at this stage of delivery. Inparticular, in this embodiment, the torqueing tool 408 has a curveddistal tip (e.g. a 90 degree curvature away from the longitudinal axis)which passes through an attachment feature 610 (e.g. a loop) on thedevice 400, maintaining attachment. The torqueing tool 408 is thenremoved from the attachment feature 610 by retracting the torqueing toolwith sufficient force as to straighten the curved end of the torqueingtool 408 to pull it out of the attachment feature 610, as illustrated inFIG. 831 . The device 400 is then left in place as an implant while thecatheter 430 is removed. In some embodiments, the torqueing tool 408 isbe made from a resilient material such as Nitinol or titanium in whichthe modulus of elasticity is less than 30E6 pounds per square inch. Inother embodiments, the torqueing tool 408 is made from ferrous ornon-ferrous metals with a cross section area less than 0.005 squareinches. These dimensions allow for the wire to be deformed. In someembodiments, the torqueing tool 408 is made from stainless steel wirethat has a dimension between 0.010 and 0.030 inches in diameter.

D. Alternative Embodiment

It may be appreciated that the torque-based pulmonary treatment device400 may take a variety of forms and include a variety of features, suchas those of the pulmonary treatment devices 10 described herein abovewhich are applicable to torque-based methods and treatments. FIGS.84A-84E illustrate another embodiment of a torque-based pulmonarytreatment device 400. Here, the device 400 includes a plurality oftissue gathering elements 402. In particular, two tissue gatheringelements 402 are shown, however it may be appreciated that additionaltissue gathering elements 402 may be present including three, four,five, six or more. In this embodiment, the tissue gathering elements 402extend radially outwardly away from the longitudinal axis 411,particularly in opposite directions from each other. Thus, in thisembodiment, the device 400 includes a first tissue gathering element402′ and a second tissue gathering element 402″, each extendingoutwardly from the longitudinal axis 411 and then curving around andback toward the longitudinal axis 411 in a loop shape. In thisembodiment, each loop forms half of the diameter of the distal end ofthe device 400 which rotates within the tissue. Therefore, each loop maybe considered as forming a radius R as indicated in FIG. 84A. In thisembodiment, each loop forms a radius R wherein R=0.5 inches. It may beappreciated that in other embodiments radius R may vary including Rvalues in the range of 0.3 to 3.0 inches.

Each tissue gathering element 402′, 402″ is comprised of shaft 412 madefrom a suitable material, such as nitinol wire, stainless steel wire,etc.). In this embodiment, the tissue gathering elements 402′, 402″ arecomprised of 0.020 inch thick ribbon that is 0.020 to 0.100 inches wide.In particular, in this embodiment, each tissue gathering element 402′,402″ is comprised of a wire ribbon. In addition, here each tissuegathering element 402′, 402″ terminates in a distal tip 405 which isformed by bending back and overlapping the ribbon to form a blunt end.FIG. 84B provides a closer view of a distal tip 405 of FIG. 84A. In thisembodiment, the ribbon material is curved back upon itself forming abend having an outer thickness of approximately 0.065 inches at itsthickest location. FIG. 84C provides another embodiment of a distal tip405 wherein the ribbon material is curved back upon itself forming abullet-nose shape. In this embodiment, the folded material creates anopening 620 within the distal tip 405 that has a length 1 and width w.In some embodiments, the opening 620 has a length of 1=5 mm. Likewise,in some embodiments, the distal tip 405 has a thickness th wherein thethickness has a maximum of 0.065 inches. It may be appreciated that thetissue gathering elements 402′, 402″ may be formed from separate shaftsor from one continuous shaft.

Referring back to FIG. 84A, in this embodiment, the device 400 alsoincludes an anchoring element 404. Here, the anchoring element 404 isdisposed in the opposite direction as the tissue gathering element 402,concentrically along the longitudinal axis 411. Here, the anchoringelement 404 comprises a coil 491. Thus, the tissue gathering element 402may be advanced into an airway and desirably positioned. The device 400is then anchored in place by deploying the coil 491 which expands withina luminal passageway or airway proximally of the tissue gatheringelement 402. In this embodiment, tissue gathering elements 402′, 402″are joined therebetween by a crimp, weld, glue joint, rivet, threadedfastener, spring element that is wrapped around parts to clampcomponents together. In this embodiment, the device 400 includes anattachment feature 610. Thus, the torqueing tool 408 is attached to theattachment feature 610 as will be described in more detail herein below.

FIG. 84D illustrates a possible position of the tissue gatheringelements 402′, 402″ during rotation and torqueing of the device 400. Asshown, the resistance of the surrounding lung tissue may initially bendthe elements 402′, 402″ as the device 400 rotates within the lung. Thus,the elements 402′, 402″ are somewhat flexible while imparting force onthe tissue. The tissue gathering elements 402′ and 402″ are shaped witha twist so that the resistance of surrounding tissue deforms them to bemore in-plane with respect to each other and along axis 411. If thetissue gathering elements 402′ and 402″ are shaped so they deform to amore vertical structure along axis 411, the tissue gathering elements402′ and 402″ will present the greatest amount of contact and thegreatest amount of bearing area on effected tissue possible as thedevice 400 is rotated.

FIG. 84E provides a top view of this embodiment of the device 400 asproduced or once implanted. In this embodiment, the elements 402′, 402″both curve downward toward the proximal end of the device 400. However,this view shows the elements 402′, 402″ out of plane (i.e. not in thesame plane) which is a common position when advanced into tissue,particularly after rotation of the device 400. Thus, the first tissuegathering element 402′ is shown set back from the second tissuegathering element 402″. FIG. 84E also illustrates that the coil designof the anchoring element 404 leaves an open passageway therethrough oncedeployed. Thus, anchoring of the device 400 does not impinge upon orblock airflow through the airway within which the device 400 isanchored.

FIGS. 85-90 illustrate example method steps of delivering a device 400having double tissue gathering elements 402′, 402″, such as in thedevice of FIG. 84A. Referring to FIG. 85 , the device 400 is loadedwithin the catheter 430 or other suitable delivery device such as aloading cartridge so that the tissue gathering elements 402′, 402″ arepositioned near the distal end of the catheter 430, ready fordeployment. In this embodiment, the portion of device 400 that protrudesfrom the catheter forms a blunt tip that allows the catheter to beadvanced through fragile airways or fragile lung tissue without causingtrauma. In this embodiment, the catheter 430 includes at least oneleverage element 700 which resides outside of the body when the distalend of the catheter 430 is positioned within the patient's body. The atleast one leverage element 700 assist the user in manipulating thecatheter 430, such as applying torque to the catheter 430 or moving thecatheter 430 longitudinally in the proximal or distal direction. In thisembodiment, the device 400 is attached to a torqueing tool 408 whichextends through the catheter 430 and exits the proximal end of thecatheter 430. In this embodiment, the torqueing tool 408 includes atorqueing handle 704 disposed near its proximal end to assist the userin grasping and applying torque to the torqueing tool 408. In thisembodiment, the device 400 is also attached to a tether 702 (e.g.suture, metallic wire (such as comprised of stainless steel, titanium,nitinol or other nickel based alloy), monofilament or multifilamentfiber, braid, polymer or ceramic or glass fiber (such as comprised ofKevlar®, carbon fiber, nylon, polyurethane, polypropylene or otherdurable material)). The tether 702 may be used to manipulate portions ofthe device 400, typically other than torqueing, such as pulling theanchoring element 404 in the proximal direction or removing the device400, to name a few. Thus, in this embodiment, the tether 702 includes atether handle 706 disposed near its proximal end to assist the user ingrasping and manipulating the tether 702. The manipulating tether mayalso be a second torqueing tool that is located at proximal end of theanchoring element 404. FIG. 85 illustrates advancement of the distal endof the catheter 430 through at least one airway AW to a target locationwithin a lung L. Thus, in this example, the distal-most end of thecatheter 430 is disposed within an airway AW. Likewise, a blood vesselBV is shown residing nearby the airway AW along with alveolar orconnective lung tissue surrounding the airway AW. It may be appreciatedthat FIGS. 85-90 are not drawn to scale; rather, the distal and proximalends of the delivery devices are prominent for focus and detail. It maybe appreciated that the catheter 430 is much longer than depicted toallow for advancement through the trachea to various airways, includingadvancement along airways past the 4^(th) generation. Likewise, it maybe appreciated that the airway AW is illustrated as bisected for thepurpose of clear viewing of the device 400 and delivery devices disposedtherein.

FIG. 86 illustrates delivery of the tissue gathering elements 402′,402″. Here, the tissue gathering elements 402′, 402″ are deployed bypushing the torqueing tool 408 in the distal direction which in turnpushes the device 400 toward the distal end of the catheter 430,revealing the tissue gathering elements 402′, 402″. This allows eachelement 402′, 402″ to extend radially outwardly, through the airway wallW, and curve around through the tissue surrounding the airway AW. Inthis example, the tissue gathering element 402″ passes in front of theblood vessel BV.

FIG. 87 illustrates torqueing steps of the method. In this embodiment,the catheter 430 and device 400 together are rotated or torqued, such asby grasping the at least one leverage element 700 and applying atorqueing force. As the device 400 rotates, the tissue gatheringelements 402′, 402″ gather up the tissue surrounding the airway AW,along with the blood vessel BV which is now shown wrapping around theairway AW. This step tensions the tissue, as indicated by the diagonalorientation of the lines depicting the tissue, by drawing in thesurrounding tissue toward the device 400. FIG. 88 illustrates furtherwithdrawal of the catheter 430, such as by pulling the at least oneleverage element 700 in the distal direction. Torque is maintained oradjusted with the use of the torqueing tool 408. The torqueing tool 408is attached to device 400 at the location such as the attachment feature610.

The device 400 is then anchored within the airway W, as illustrated inFIG. 89 . In this embodiment, this is achieved by retracting thecatheter 430 so as the expose the anchoring element 404 whilemaintaining position of the device 400 or pushing the anchoring element404 in the distal direction by manipulation of the tether handle 706 toactuate the tether 702. In this embodiment, the anchoring element 404comprises a coil which expands against the inner surface of the airwayAW. It may be appreciated that in some embodiments the coil is wound inthe opposite direction as the torqueing applied to the tissue gatheringelements 402′, 402″. Thus, over time, any unwinding of the device 400will cause the coil to expand, further anchoring the device 400.Referring to FIG. 90 , the torqueing tool 408 and tether 702 are thendisengaged from the device 400 and removed along with the catheter 430.Thus, the device 400 is left behind as an implant. It may be appreciatedthat the implant is typically so securely positioned that it is unableto move around sufficiently to cause coughing and other uncomfortablesymptoms for the patient.

It may be appreciated that in some embodiments, the torqueing tool 408is configured to assist in detachment from the device 400. FIGS. 91A-91Cillustrate an embodiment of such a torqueing tool 408. FIG. 91Aillustrates a torqueing tool 408 comprising a shaft 720 having a hookedend 722. The hooked end 722 is formed from an approximately 90 degreebend in the shaft 720 adjacent to its distal tip but the bend can rangefrom 10 to 90 degrees to allow the hook to be easily pulled off thedevice 400 or it may range from 90 to 180 degrees to hook through andaround the attachment end 406 (shown in FIG. 91C) of device 400 sotraction is maintained. In addition, the shaft 720 has a curvature 724set a distance proximally from the hooked end 722. In some embodiments,the curvature 724 is disposed 0.05 to 1.0 inches from the hooked end 722of the tool 408. The curvature 724 bends the shaft 720 radiallyoutwardly from a longitudinal axis 726 extending through the proximalend of the shaft 720. In some embodiments, the curvature 724 bends theshaft 720 radially outwards by 0 degrees, wherein 0 is in the range of 1to 90 degrees. The torqueing tool 408 is comprised of a flexible orresilient material which allows the curvature 724 to straighten whenretracted into a tube or catheter 430. FIG. 91B illustrates the tool 408retracted within a catheter 430. The hooked end 722 is sized to maintainits hooked shape while retracted within the catheter 430. Thus, thelength of the hooked end 722 (and therefore, overall width of the distalend of the torqueing tool 408) typically does not exceed 0.070 inches.Consequently, the torqueing tool 408 is able to remain attached to anattachment end 406 of a torque-based pulmonary treatment device 400while the hooked end 722 resides within the catheter 430. This allowsthe tool 408 to torque the device 400 as desired. Once the desiredtorqueing has been achieved, the torqueing tool 408 may be removed fromthe attachment end 406 by simply advancing the tool 408. This allows thehooked end 722 to spring radially outwardly due to the preset curvature724, as illustrated in FIG. 91C. This disengages the hooked end 722 fromthe attachment end 406. The tool 408 can then be retracted into thecatheter 430 once again and removed, leaving the device 400 behind.

In some embodiments, as illustrated in FIG. 91D, the torqueing tool 408includes a cross drilled end hole 725 which passes through the hookedend 722 of shaft 720, so a hitch wire 727 can be threaded through thehole 725. This holds the torqueing tool 408 in engagement with thedevice 400, such as to the attachment end 406 or to an attachmentfixation feature 610. The end hole 725 may be drilled through thetorqueing tool 408 in any orientation, relative to the axis along thelength of the shaft 720 of the torqueing tool 408. FIG. 91D illustratesthe torqueing tool 408 that has been inserted through hole or slot of anattachment feature 610. The hitch wire 727 has been threaded through thetorqueing tool 408 end hole 725 to connect the torqueing tool 408 to thedevice 400. In some embodiments, the hitch wire 727 is made frommetallic wire, nitinol, suture, polymer, monofilament line, braidedmaterial, glass, organic fiber or shape memory NiTi wire. The distal endof the hitch wire 727 is typically shaped to form a non-straight endshape, such as a curl or loop, that is designed to create drag orpulling resistance as it is pulled through the torqueing tool 408 endhole 725. This prevents the hitch wire 727 from accidentally beingpulled out prematurely. In some embodiments, the hitch wire 727 is asuture that is threaded through the end hole 725 and tied to form acomplete loop that is exposed outside the delivery system so as to beaccessible to the user. By forming a loop, the hitch wire 727 cannot beaccidentally removed. Alternatively, the user can easily cut the loopand withdraw the hitch wire 727 at any time the torqueing tool 408 needsto be removed from device 400.

FIG. 92 outlines steps of an example method of treating a patient with atorque-based pulmonary treatment device 400. To begin, the first step800 describes that the device 400 is advanced into a lung. It may beappreciated that in some embodiments such advancement is through themediastinum, through the trachea, through an airway, through the chestwall, through an opening in the chest, through blood vessels, throughwall or barriers that define the previously described structures in thebody or between ribs, to name a few. Likewise, in some embodiments, suchadvancement is with the use of a trocar, guide introducer, catheter,endoscope or bronchoscope. The second step 802 describes coupling thedevice 400 to lung tissue. In some embodiments, such coupling includespulling back to engage the lung tissue, advancing to engage the lungtissue, rotating to engage the lung tissue, unsheathing at least aportion of the device 400 to allow expansion of the device 400,unsheathing at least a portion of the device 400 to allow bending of thedevice 400, advancing at least a portion of the device 400 through anairway wall, removing a constraint to allow expansion of the device 400(such as removing a sleeve, removing a pin, removing a hitch wire, cableor knot, melting a polymer, unzipping a seam, splitting a sheath wall,applying a current to melt a metal connection, etc.), deploying aballoon to expand at least a portion of the device 400, pulling a drawstring to actuate at least a portion of the device 400, pushing a pushrod to actuate at least a portion of the device 400, shortening astructure to radially expand at least a portion of the device 400,pulling a tether to pull at least a portion of device 400, bending orrotating a torqueing tool to rotate at least a portion or feature ofdevice 400, barbing at least a portion of the device 400 into tissue, orallowing self-expansion of at least a portion of the device 400, to namea few. The third step 804 describes rotating the device 400 to applytorque to lung tissue. In some embodiments, such rotation includestwisting to apply torque, pulling tissue along tangent, pulling tissuein an arc direction, curvilinear pulling, creating tension along aperpendicular plane relative to a longitudinal axis of the device,non-uniaxial tensioning of tissue, lung volume reduction by rollingtissue around a hub or tissue gathering element 402 spooling tissue onthe device, winding tissue around the device, shortening tissue in thelung by winding, compressing lung volume or reducing lung volume bycompressing tissue around a tissue gathering element 402 or bycompressing tissue by wrapping tissue over itself as it's wound around atissue gathering element 402 to name a few. Optionally, a fourth step806 is included which describes pulling the device 400 to create auni-axial displacement, translation, stress, strain or tension in thelung. And the fifth step 808 describes anchoring the device 400 withinthe lung. In some embodiments, this includes releasing stored elasticenergy to engage an anchoring element 404, hooking an anchoring element404 into tissue, expanding the anchoring element 404 against lung tissueor otherwise coupling the anchoring element 404 to lung tissue socounter rotation of device 400 is resisted by the tissue the anchoringelement 404 is coupled to.

FIG. 93 illustrates an embodiment of the placement of two torque-relatedpulmonary treatment devices (a first torque-related pulmonary treatmentdevice 400′ and a second torque-related pulmonary treatment device400″). In this embodiment, each device 400′, 400″ is comprised of atissue gathering element 402 a and another tissue gathering element 402b, each extending outwardly and then curving around and back in a loopshape, such as illustrated in FIG. 84A. Likewise, the first device 400′includes a first anchoring element 404′ and the second device 400″includes a second anchoring element 404″. Referring back to FIG. 93 ,the first torque-related pulmonary treatment device 400′ is positionedso that its tissue gathering elements 402 a, 402 b are disposed within afirst airway AW1. Similarly, the second torque-related pulmonarytreatment device 400″ is positioned so that its tissue gatheringelements 402 a, 402 b are disposed within a second airway AW2. Torque isapplied to each device 400′, 400″ either simultaneously or in series, sothat their tissue gathering elements 402 a, 402 b to gather up thesurrounding tissue (as indicated by the twisted configuration of theblood vessels BV). In some embodiments, torque is applied to the firstdevice 400′ in a first direction and torque is applied to the seconddevice 400″ in an opposite direction. In any case, torqueing re-tensionsthe lung, as described hereinabove. In this embodiment, the devices400′, 400″ are then both anchored within a common airway proximal to thefirst and second airways AW1, AW2, such as in an ostium OS. In thisembodiment, each anchoring element 404′, 404″ has the shape of a coil.In such embodiments, it is desirable that the coil is wound in adirection opposite to the direction of the torque/rotation of the tissuegathering elements 402 a, 402 b. Thus, any unwinding of the torque wouldfurther expand the corresponding anchoring element. In FIG. 93 , theanchoring elements 404′, 404″ are positioned within the ostium OS so asto overlap with each other. In some embodiments, the anchoring elements404′, 404″ are positionable so as to overlap and in other embodiments,the anchoring elements 404′, 404″ are manufactured as intertwined so asto be delivered in an intertwined configuration. In any case, theanchoring elements 404′, 404″ take up minimal space when positioned inthe same or overlapping portions of the ostium OS or airway. Likewise,when the devices 400′, 400″ are torqued in opposite directions, thedevices 400′, 400″ are able to counterbalance each other, therebyplacing less load on the ostium OS or airway at the point of anchoring.

FIG. 94 outlines steps of an example method of treating a patient withtwo pulmonary treatment devices. The pulmonary treatment devices may betorque based or linear so as to lead to the following combinations: twolinear pulmonary treatment devices 10, two torque-based pulmonarytreatment devices 400 or one linear pulmonary treatment device 10 andone torque-based pulmonary treatment device 400. To begin, the firststep 820 describes advancing a first pulmonary treatment device(torque-based on linear) into a lung at a first target location. Thesecond step 822 describes advancing a second pulmonary treatment device(torque-based on linear) into the lung at a second target location. Thethird step 824 describes actuating the first and/or second pulmonarytreatment devices to tension the lung. And, the fourth step 826describes coupling the pulmonary treatment devices together to maintaintensioning of the lung.

FIG. 95 outlines steps of an example method of treating a patient with apulmonary treatment device while monitoring with imaging. The pulmonarytreatment device may be linear or torque-based. To begin, the first step828 describes advancing the pulmonary treatment device into a lung. Thesecond step 830 describes coupling a first portion of the pulmonarytreatment device to lung tissue. The third step 832 describesmanipulating the pulmonary treatment device to cause lung volumereduction. The fourth step 834 describes acquiring a chest image, suchas via computed tomography (CT), fluoroscopy or any other imaging methodor modality that has been described herein or other data may be assessedsuch as any of the measurable physiologic changes listed herein thatindicate improved breathing in COPD patients. The chest image or data isthen analyzed to determine if the diaphragm is desirably elevated (asdescribed in the fifth step 836) or to determine if any of themeasurable physiologic changes listed herein that indicate improvedbreathing in COPD patients has been shown. If not, the method is thenrepeated from the third step 832 wherein the pulmonary treatment deviceis further manipulated. If so, then manipulation ceases, as indicated inthe sixth step 838. The device is then anchored in place, as indicatedin the seventh step 840.

FIG. 96 outlines steps of an example method of treating a patient with apulmonary treatment device while monitoring with the use of aventilator. The pulmonary treatment device may be linear ortorque-based. To begin, the first step 842 describes attaching thepatient to the ventilator. The ventilator should be set to providebreathable gas into the patient until a constant peak pressure isachieved during each breathing cycle. The required volume of deliveredbreathable gas to achieve the constant peak pressure should be noted.The second step 843 describes advancing the pulmonary treatment deviceinto a lung. The third step 844 describes coupling a first portion ofthe pulmonary treatment device to lung tissue. The fourth step 845describes manipulating the pulmonary treatment device to cause lungvolume reduction. The fifth step 846 describes monitoring a decrease inventilation volume of breathable gas that is required to achieve theconstant peak pressure. In some instances, a volume reduction of 20-1500cc is desired, however, a volume reduction of 300-500 cc is typicallyconsidered desirable. The volume reduction is then analyzed to determineif it is sufficiently reduced (as described in the sixth step 847). Ifnot, the method is then repeated from the fourth step 845 wherein thepulmonary treatment device is further manipulated. Alternatively, anadditional device 400 may be installed to further reduce the volume ofbreathable gas that must be ventilated into the patient to achieve theconstant peak pressure during each breathing cycle. If the volumereduction is sufficiently reduced (as described in the sixth step 847),then manipulation ceases, as indicated in the seventh step 848. Thedevice is then anchored in place, as indicated in the eighth step 849.

In some embodiments, the torque-based pulmonary treatment device 400 ispositioned in the lung by a surgical procedure, such as a minimallyinvasive video assisted portal procedure or an open procedure. In suchembodiments, the device 400 is not anchored in place by stabilizationwithin an ostium or airway. Rather, the device 400 is anchored withinlung tissue by suturing or balancing torque forces. FIGS. 97A-97Cillustrate an embodiment of a device 400 which may be positioned in thelung by a surgical procedure. Here, the device 400 has a first pair oftissue gathering elements 402 a, 402 b, each tissue gathering element402 a, 402 b extending outwardly radially outwardly from a longitudinalaxis 411 and then curving around and back toward the longitudinal axis411 in a loop shape, such as illustrated in FIG. 84A. The device 400also has a second pair of tissue gathering elements 402 c, 402 d. Inthis embodiment, these tissue gathering elements 402 c, 402 d mirror thefirst pair of tissue gathering elements 402 a, 402 b around an axis 850which is perpendicular to the longitudinal axis 411. Thus, in thisembodiment, both pairs of tissue gathering elements (402 a, 402 b) (402c, 402 d) extend radially outwardly from the longitudinal axis 411 andthen curve toward the axis 850 before curving back toward thelongitudinal axis 411. In some embodiments, the device 400 includes acoupler 852 to connect the tissue gathering elements 401 a and 402 b andpossibly the anchoring elements 402 c and 402 d. In some embodiments,the device 400 includes an attachment feature 854 which is used toattach a torqueing tool 408 to the device 400 to rotate the distal endof device 400 to apply torqueing loads to the surrounding lung tissue. Asuture or other fixation device may be used to attach the attachmentfeature 854 to the lung tissue within the lung L.

FIG. 98 illustrates the device 400 of FIGS. 97A-97C in use. FIG. 96shows access to lung tissue of the lung L with the use of a trocar orcannula 860. The device 400 loaded within a distal end of deliverycatheter 430 and the distal end of the catheter 430 is advanced throughthe cannula 860 to a target location within the lung L. The first pairof tissue gathering elements 402 a, 402 b are then deployed and torquedso as to gather up a first portion of lung tissue LT1. The second pairof tissue gathering elements 402 c, 402 d are then deployed and torquedso as to gather up a second portion of lung tissue LT2. In thisembodiment, the first portion of lung tissue LT1 and the second portionof lung tissue LT2 are torqued in opposite directions. Such torqueing inopposite directions creates a counter-balance, anchoring the device 400in place. Alternatively or in addition, the device 400 may be anchoredin place by joining the fixation feature 854 to the lung tissue with theuse of a fixation element, such as a suture, staple, tissue glue,coagulated blood or by using other devices that are sufficientlybiocompatible and designed to connect tissue and device components totissue.

It may be appreciated that in some embodiments, one or more torque-basedpulmonary treatment devices 400 may be used to “wad up” tissue, so as toclose off airways, close communication of gas in diseased tissue orclose off gas exchange in the lung. This may be utilized to tune wherepreferential filling occurs. Thus, it may be desired to block flow toseverely diseased parts of the lung so that filling preferentiallyoccurs in the less severe parts of the lung. Any devices describedherein may be used to block the flow of gas in one or both directions tocause atelectasis or shrinkage of volumes of the lung. Ideally, portionsof the lung can be completely blocked off to cause atelectasis. Suchmethods may also may be used to stop chronic air leaks in lung fistulasthat are currently very difficult to treat effectively. Such small leaksin the pleura typically cause repeated pneumothorax incidents. Thus, thetorque-based pulmonary treatment devices may be a minimally invasivetreatment to block the leak by twisting tissue to block air flow.

Additionally, these devices and methods may be used to block, reduce orgenerally regulate the flow of blood through the lung so as to minimizethe flow of insufficiently or minimally oxygenated blood that flowsthrough areas of lung with severe damage. Patients will benefit byreducing the flow of blood that is under-oxygenated because mixing thisblood with fully oxygenated blood, as the blood streams exit the lungs,allows for oxygen dilution that leads to reduced oxygen as a percentageof blood volume in the patient's vascular system. Blocking the flow ofunder-oxygenated blood before the blood exits the lungs actuallyincreases the percentage of blood oxygen in the patient's system. Theother benefit to blocking the flow of blood through areas in the lungthat are severely damaged by emphysema is that the CO2 that is normallynot sufficiently transported out of the blood in these damage regions soit should not be allowed to be mixed with low CO2 or normallyconditioned blood where the blood streams combine and exit the lungs. Byblocking blood flow in severe areas of the lung, the blood that doesexit the lungs carries a higher percentage of oxygen and a lowerpercentage of CO2 than the levels of these gases that would otherwise bepresent in typical emphysema or COPD patients.

E. Placement

Many of the pulmonary treatment devices (torque-based and linear)described herein may be placed in any lung, lobe, mainstem segment,segment, sub-segment or even farther down the airway tree. Likewise,many of the devices may be placed directly through the chest wall intothe lung or through the wall of the main bronchi to access pockets ofdestroyed parenchyma. Many of the devices may be implanted via openchest procedure or with the use of any type of endoscope.

The number, type and placement location of the devices are chosen tobest treat the disease type and disease state of the patient. Restoringtension and lung elastic recoil in the lung with these devices mitigatesthe symptoms typically experienced by COPD patients and patientssuffering from other lung conditions. The devices described herein arecapable of producing a tremendous amount of work to tension lung tissue.These lung treatments have been shown to induce biologic feedback in thelungs that further enhances the reduction of symptoms, restoration oflung elastic recoil, enhancement of the lifting displacement of thediaphragm and general restoration of breathing mechanics in patients.Treatment magnitude, during each device deployment, is controlled bycontrolling the amount of force that is placed on the tissue, the lineardistance that the proximal or distal end of the device is translated orthe amount of rotation that is applied to a treatment device that actsupon tissue with the application of torque. Additionally, linear forceand linear translation as well as the application of torque may becombined with any of the embodiments provided herein to enhance theamount of work performed on the lung tissue. By controlling theseforces, a patient may be treated with one or more devices in a singlemajor lobe of the patient's lung, more than one major lobe or all of themajor lobes. It may be appreciated that a patient has four major lobesin the lung. It may also be appreciated that major lobes may alsoinclude the middle lobe in the right lung and the Lingula in the leftlung of a patient.

In some embodiments, the first treatments target the lobes with themaximum amount of tissue damage, as can be determined using quantitativecomputed tomography (CT) analysis (CT image file post processing) thatanalyzes the least dense portions of the lung. Any number of CT analysesmay be studied to determine the most severe portions of each lobe andthe magnitude and nature of the damage. Patients with heterogeneous lungdamage typically present with severely damaged upper lobes and generallypreserved lower lobes. These patients should be treated withimplantation in the upper lobes and possibly not in the lower lobesduring the initial treatments. If the patient doesn't respondadequately, additional devices may be implanted and those may be addedto the upper lobes or they may be implanted in the lower lobes tobalance the tensioning forces in the lungs.

Homogeneous patients generally present with mild to severe damage in allfour major lobes. It is preferable to treat one, two or three lobes in asingle lung during a single intervention or implantation event so thatmucus, bacteria, fungus or other infectious contaminants are nottransferred from one lung to the other during a treatment. That waybilateral infections are avoided. If all major lobes are to be treated,it is preferable to treat each lung during one of two total procedures.A single lobe may be treated during a single procedure or a combinationof lobes may be treated during a series of treatments. If the deliverymethods described herein may be used to deliver into a patient eachdevice 400 in less than 10 minutes or with the use of 10 or less minutesof energized fluoroscope time, patient risk to x-ray exposure and riskof hypoxemia will be reduced. In homogeneous patients, it is importantto treat at least all four major lobes. In order to uniformly lift thediaphragm, all patients preferably benefit by receiving treatment in atleast one lobe in each of the patient's two lungs. Treatment successrequires that the treatment gathers a threshold amount of relativelyloose tissue to a slightly tightened condition that is approximatelyphysiologically normal. If a patient does not respond positively to atreatment, this only indicates that the dose was not sufficient and moredevices should be placed to transcend the threshold minimum tissuedisplacement to tension the loose elongated tissue, hold airways open toallow expiration of gas during exhale events and to lift the diaphragmenough to restore diaphragm pumping motion. The pulmonary function testslisted herein are excellent indicators of positive and adequateresponse.

It may be appreciated that the more severely affected patients mayrequire treatments that are delivered in stages that progressively builda dose level to accomplish several possible outcomes. For thesepatients, low doses may result in some elimination of slack in the lungtissue but inadequate tensioning to lift the diaphragm enough or it mayprovide an inadequate dose to delay airway closure during exhalation.With implantation of additional devices, the patient may experiencesufficient tensioning to lift the diaphragm and hold airways open enoughto show positive reduction of symptoms described herein but not enoughof a dose to adequately tension the majority of the lung volume. Withimplantation of additional devices, the patient may show positivereduction of symptoms on a large number of the symptoms listed herein.At this stage, the treatment may be successful, but the duration of thebenefit may still be improved. Implantation of a larger number ofdevices or implantation with a higher degree of displacement, force, ortorque (or higher level of a combination of displacement, force, andtorque) will present such a high degree of stress and strain on the lungtissue that it responds in the same way that tissue responds to typicaltissue injury. This can be quite beneficial to the patient.

The lung tissue is quite radio transparent using typical medical imagingsuch as fluoroscopy, computed tomography (CT), and X-ray imaging.However, if the lung tissue is stressed sufficiently, the tissuehydrates and this presents in images as consolidation with opacitiesthat sometime present with local consolidates. The tissue goes into awound healing cascade that manifests as opacities in the tissue betweendevices, between devices and the pleura, and between anatomical featuresof the lung. Wherever the tissue is stressed and strained sufficiently,bands of opaque shades present in the images that indicate that thetreatment dose has been applied sufficiently to yield a maximum effectthat is possible in these severe COPD and emphysema patients. As thewound healing cascade progresses, the end stage presents as tissuehealing and contraction which further enhances the lifting of thediaphragm and tensioning of the lung tissue throughout the patient'slung. This contraction adds a high impact to boost the benefit of thetreatment and the combination of slight scaring in the contracted tissueseems to reinforce the tissue in a way that allows the effect to bemaintained for long periods of time such as 1 to 10 years but normally3-5 years. The wound healing cascade can be managed using steroidaltreatments to control the rate of healing, slightly alleviatecontraction and the magnitude of effect. This also manages the pain thatis sometime associated with the high degree of tensioning that thispresents. In addition, this minimizes symptoms that often lead theattending physicians into erroneously believing that the patient suffersfrom pneumonia, such as elevated body temperature and flu symptoms.Additionally, because these patients already present with compromisedimmune mechanisms, they are more susceptible to the effects of infectionand colonization of inherent fungus in the lung, so the use of steroidtreatment to manage stress induced opacity, is recommended. Normallyantibiotic treatments tend to mitigate the effect of steroids so a mixof antibiotic treatments may be prescribed but the major drug regimenshould be dominated by steroids or some nonsteroidal anti-inflammatorydrug such as the (NSAID) class that is commonly referred to asIbuprofen.

After straining lung tissue, airway walls, blood vessels, pulmonaryarteries, pulmonary veins, alveoli, alveolar ducts, smooth muscle,interstitial connective tissue, capillary beds, elastic fibers andcollagen fibrils sufficiently to cause a wound healing response, theinflammatory phase is the first phase of healing and is characterized byhemostasis and inflammation. Hemostasis is initiated during the exposureof collagen during wound formation that activates the intrinsic andextrinsic clotting cascade in the available vasculature. In addition,the injury to tissue causes a release of thromboxane A2 andprostaglandin 2-alpha to the wound bed causing a potent vasoconstrictorresponse. Furthermore, the extravasation of blood constituents providesthe formation of the blood clot reinforcing the hemostatic plug. Thisinitial response helps to limit hemorrhage and provides an initialextracellular matrix for cell migration. Platelets are among the firstresponse cells that play a key role in the formation of the hemostaticplug. They secrete several chemokines such as epidermal growth factor(EGF), fibronectin, fibrinogen, histamine, platelet-derived growthfactor (PDGF), serotonin, and von Willebrand factor. These factors helpstabilize the wound through clot formation and also attract and activatemacrophages and fibroblasts. They also act to control bleeding and limitthe extent of injury. Platelet degranulation activates the complementcascade, specifically C5, a potent neutrophils chemotactic protein.Vasoactive mediators and chemokines are released by the activatedcoagulation cascade, complement pathways, and parenchymal cells whichplay a key role in the recruitment of inflammatory leukocytes to injuredskin.

After hemostasis is achieved, capillary vasodilatation and leakageresult secondary to local histamine release by the activated complementcascade. The increased blood flow and altered vascular permeabilityallow for the migration of inflammatory cells to the wound bed. Thepresence of foreign organisms further stimulates the activation of thealternate complement pathway. Complement C3 activation results in acascade of non-enzymatic protein cleavage and interactions thateventually stimulate inflammatory cells and the lysis of bacteria.

The second response cell to migrate to the wound after complementactivation and platelet recruitment is the neutrophil. It is responsiblefor debris scavenging, complement-mediated opsonization and lysis offoreign organisms, and bacterial destruction via oxidative burstmechanisms (i.e., superoxide and hydrogen peroxide formation).Neutrophils kill bacteria and decontaminate the wound from foreigndebris. These wastes are later extruded with the eschar or phagocytosedby macrophages. Macrophages are important phagocytic cells that play akey role in wound healing. They are formed from monocytes stimulated byfragments of the extracellular matrix protein, transforming growthfactors and monocyte chemoattractant protein 1. In addition to directphagocytosis of bacteria and foreign materials, macrophages secretenumerous enzymes and cytokines; collagenases, which debride the wound;interleukins and tumor necrosis factor (TNF), which stimulatefibroblasts and promote angiogenesis; and transforming growth factor(TGF), which stimulates keratinocytes. Macrophages also secreteplatelet-derived growth factor and vascular endothelial growth factorwhich initiate the formation of granulation tissue and thus initiate thetransition into the proliferative phase and tissue regeneration.

The proliferative phase is the second phase of wound healing and it ismarked by epithelialization, angiogenesis, granulation tissue formation,and collagen deposition. Epithelialization occurs within hours afterinjury in wound repair. With an intact basement membrane, the epithelialcells migrate upwards in the normal pattern as occurs in a first-degreeskin burn whereby the epithelial progenitor cells remain intact belowthe wound and the normal layers of epidermis are restored in 2-3 days.If the basement membrane has been damaged, then the wound peripheryre-epithelializes the wound. Neovascularization is necessary to delivernutrients to the wound and help maintain the granulation tissue bed.Angiogenesis has been attributed to many molecules including fibroblastgrowth factor, vascular endothelial growth factor, transforming growthfactors, angiogenin, angiotropin, angiopoietin 1, tumor necrosis factoralpha, and thrombospondin. In emphysematous lung tissue where there islittle to no vascularization, this critical nutrient supply bycapillaries is insufficient to sustain the tissue deposition in thegranulation phase and may result in a chronically unhealed wound in someportions of the patient's lungs. The proliferative phase ends withgranulation tissue formation. This new stroma begins to invade the woundspace close to four days after injury. The new blood vessels at thistime have provided a facilitated entry point into the wound to cellssuch as macrophages and fibroblasts. Macrophages continue to supplygrowth factors stimulating further angiogenesis and fibroplasia. Thesecreted platelet-derived growth factor and transforming growth factorsalong with the extracellular matrix molecules stimulate fibroblastsdifferentiation to produce ground substance and then collagen.Fibroblasts are the key players in the synthesis, deposition, andremodeling of the extracellular matrix providing strength and substanceto the wound.

The third and final phase of wound healing is the maturational phase.This is characterized by the transition from granulation tissue to scarformation. Close to two weeks after injury, the wound undergoescontraction, ultimately resulting in a smaller amount of apparent scartissue. Collagen deposition by fibroblasts continues for a prolongedperiod with a net increase in collagen deposition reached after threeweeks from tissue injury. The entire process is a dynamic continuumdictated by numerous growth factors and cells with an overlap of each ofthe three phases of wound healing to provide continued remodeling. Thewound is estimated to reach its maximal strength at one year, with amaximal tensile strength that is 70% of normal lung parenchyma.

F. Implant Removal

It may be appreciated that in some instances the device 400 may need tobe removed. It may be determined that the device 400 may need to beremoved to be repositioned if the initial deployment isn't ideal or thismay be determined after the deployment has been performed. If theinitial deployment has been misplaced or too much torque has beenapplied to the tissue, it may be desired to recapture and adjust thedevice 400 to remove torque based stress on the lung tissue. Or it maybe desired to recapture and adjust the device 400 to reduce linear oruniaxial tension that the device 400 is imparting on the lung tissue. Itmay also be appreciated that a torqueing tool 408 may be releasablycoupled to the far proximal end of the device 400 at an attachmentfeature 610 near the proximal end that allows the user to control thedeployment of the anchoring element 404 and to allow for the possibilityof removing the device 400 in an orderly manner.

G. Torqueing Tool

It may be appreciated that in some instances the torqueing tool 408 isprovided to the end user already attached to device 400. In someembodiments, one or more torqueing tools 408 are releasably attached tothe device 400 during a manufacturing step to spare the end user frommaking the attachments during the procedure. In other embodiments, thetool 408 is attached by the user, such as just before delivering device400 to the patient or while delivering device 400 to the patient. Insome embodiments, the torqueing tool 408 is made from metal or organicmaterials such as carbon fiber, ceramic, plastic, glass or a combinationof these materials. In some embodiments, the torqueing tool 408 isterminated with a handle or a wire form loop that can accommodate afinger or thumb to facilitate rotation. The distal end section of thetorqueing tool 408 is resilient so as to pass through bends in humananatomy or common bends in a typical endoscope or bronchoscope. However,stiffness of the shaft 720 may vary to reliably transmit torqueefficiently.

In some embodiments, torque transmission is such that a single turn atthe control or user actuated end results in at least 1/10^(th) of arotation or more at the device 400 end. The torqueing tool 408 may beinserted through a hole, slot or loop in the device 400 to retain thetorqueing tool 408 so torque transmission may be communicated to device400. The torqueing tool 408 may be snap fit, interference fit, orloosely fit through the device 400 attachment feature 6104 so that itmay be easily removed during a desired time. As described previously,the distal tip of the torqueing tool 408 may be cross drilled to accepta hitch pin, wire or thread that locks the torqueing tool 408 engaged inthe attachment feature 610 of device 400 until such time as the hitchpin, wire or thread has been pulled out or broken to allow the releaseof the torqueing tool 408.

H. Distal Tip

As mentioned previously, the distal tip 405 of the tissue gatheringelements 402 may have a variety of forms. As previously shown in FIG.63A, in some embodiments, the distal tip 405 is atraumatic and has ablunt shape, such as a ball or other rounded shape. In thisconfiguration, the tissue gathering element 402 may be more inclined totrack along the inside lumen of an airway if the airways are stillpreserved. However, in nearly all cases, they are not. If the distal tipincludes a ball that is smaller than 0.060 inches diameter, it willstill be capable of penetrating the wall of an airway to engageconnective alveoli instead of manipulating airways alone. In otherembodiments, as previously shown in FIG. 63B, the distal tip 405 has asharp shape, configured to pierce and/or penetrate tissue. In otherembodiments, as previously shown in FIG. 63C, the distal tip 405 has ananchoring shape, such as a fish-hook or other shape which is configuredfor piercing or penetrating tissue while resisting withdrawal from thetissue.

As mentioned previously, in some embodiments, the device 400 is madefrom round wire and in some embodiments the round wire has beenflattened at the distal tip or any other portion of the tissue gatheringelement 402 to add bearing area. Likewise, in other embodiments, thedevice 400 is made from ribbon which already has a flattened shape. Insuch instances, the ribbon can optionally be twisted so as to form thedistal tip 405. FIG. 99A illustrates such twisting of a ribbon 900.Here, the ribbon 900 is shown extending in a plane wherein its free end902 is twisted 90 degrees so as to reside in a perpendicular plane.

FIGS. 99B-99D illustrate additional embodiments of distal tips 405having twisted ends. FIG. 99B illustrates a portion of a tissuegathering element 402, particularly its distal tip 405. Here, the distaltip 405 is formed from a ribbon 900 that is twisted so that its free end902 is flat forming a planar surface 903 that resides in a planeconfigured to maximize contact area with tissue when engaging the tissuegathering elements 402 with the tissue, such as during torqueing. Insome embodiments, the twist is approximately 90 degrees, however it maybe appreciated that any amount of twist may be used including variousdegrees up to 90 degrees or in a range of 1 to 90 degrees. In otherembodiments, the twist is beyond 90 degrees. In addition, in thisembodiment, the edge 904 of the free end 902 is blunt or rounded. Thisassists in smooth advancement of the distal tip 405 through deliverydevices. FIG. 99C illustrates another embodiment of the distal tip 405formed from a ribbon 900 that is twisted so that its free end 902 isflat forming a planar surface 903 that resides in a plane configured tomaximize contact area with tissue when engaging the tissue gatheringelements 402 with the tissue, such as during torqueing. In thisembodiment, the edge 904 of the free end 902 has a point 906 to assistin forward penetration but has angled corners 908 straddling the point906 so as to reduce any friction or digging into delivery devices duringadvancement. FIG. 99D illustrates another embodiment of the distal tip405 formed from a ribbon 900 that is twisted so that its free end 902 isflat forming a planar surface 903 that resides in a plane configured tomaximize contact area with tissue when engaging the tissue gatheringelements 402 with the tissue, such as during torqueing. In thisembodiment, the edge 904 of the free end 902 has an elongate taperending in a ball 914. In some embodiments, this distal tip 405 is formedby putting a very slow long taper on the ribbon 900 and melting its tipback to form the ball 914.

Example System for Torque-Based Treatment

Both the pulmonary treatment device 10 and the torque-based pulmonarytreatment device 400 are sized and configured to be delivered by adelivery device that is insertable into the lung, such as a steerablescope (e.g. bronchoscope 20), catheter or other delivery system. Asdescribed previously, such as in relation to FIGS. 31A-31B, an exampledelivery device is a bronchoscope 20. In this example, the bronchoscope20 includes a bronchoscope body 200 and an insertion cord 202. Theinsertion cord 202 is advanced into the endobronchial tree of thepatient and the bronchoscope body 200 remains outside of the patient,typically grasped by the operator's non-dominant hand. The insertioncord 202 contains a fiberoptic bundle for light and image transmission,tip bending control wires and a working channel. The working channelcontinues into the bronchoscope body 200, exiting at the working channelport 204. The working channel 210 extends through the tip 208, allowingdelivery of the pulmonary treatment devices 10, 400 therefrom.

In some embodiments, the pulmonary treatment device 10 is loadeddirectly into the working channel port 204 and advanced through theworking channel 210 for delivery from the insertion cord tip 208.However, in other embodiments, the device 10 is pre-loaded into anintroducer which is advanceable into the working channel 210 fordelivery therefrom.

FIG. 32 previously illustrated an embodiment of an introducer 220 havinga pre-loaded pulmonary treatment device 10. In this embodiment, theintroducer 220 comprises an elongate tube 222 having a first end 224 anda second end 226. The introducer 220 is typically strong enough to keepthe device 10 from distorting from a straight configuration and hardenough that the device 10 cannot indent into the wall of the introducer220, particularly during the sterilization process that involves heatingto 130-180° C.

FIG. 100 illustrates an embodiment of a torque-based pulmonary treatmentdevice 400 prepared for pre-loading in an introducer 220. Here, thedevice 400 is prepared for pre-loading by having the torqueing tool 408,hitch wire 727 and tether 702 attached thereto. In particular, thetorqueing tool 408 is attached to an attachment feature 610 on thedevice 400. Thus, the torqueing tool 408 is able to torque the device400 by rotation of its handle. In this embodiment, its handle has a loopshape for easy grasping and rotational leverage. The hitch wire 727 isattached to the torqueing tool 408 to maintain its engagement aspreviously described in relation to FIG. 91D. In this embodiment, itshandle has a T shape for ease of pulling and pushing the hitch wire 727.The tether 702 is attached to the anchoring element 404 and its handleis shaped for ease of use and to distinguish from the other handles.These tools (i.e. torqueing tool 408, hitch wire 727, tether 702) extendthrough the introducer 220 so that the device 400 resides beyond thefirst end 224 of the introducer 220 and the handles of the tools resideproximal to the second end 226 of the introducer 220. Thus, in thisarrangement, the device 400 is not confined within the introducer 220 ina straightened configuration. In some instances, implantable materials,such as nitinol, can be damaged if they are stressed in packaging andthen exposed to heat that exceeds 25 degrees C. during shipment as thestress on the device is elevated with the additional heat. In someembodiments, the device 400 is packaged in this manner so that anyheating due to transit or sterilization will not introduce any potentialdamage or inadvertent shape setting while the device 400 is constrainedin a straightened configuration. It is advantageous to ship the device400 in an unstressed configuration. It is also advantageous to ship thedevice 400 in an unstressed configuration but already attached to thetorqueing tool 408, tether 702 and the hitch wire 727 so the assemblydoes not have to be attached by the user and the device 400 may bequickly and easily be retracted into the introducer 220 by simplypulling on one or more of the attached tools to pull device 400 into theintroducer 220 through the first end 224.

FIG. 101 illustrates the device 400 preloaded into the introducer 220.This can be achieved by retracting the device 400 into the introducer220 by pulling the tether 702. Alternatively, or in addition, theintroducer may be advanced over the device 400. Finally, device 400 maybe advanced into the introducer 220 by advancing the tissue gatheringelement 402 into the introducer 220 by inserting it into the second end226 of the introducer 220. Thus, the device itself is disposed withinthe introducer 220 while the handles of the torqueing tool 408, hitchwire 727, tether 702 extend from the second end 226 of the introducer220. The introducer 220 is then ready to be advanced into or coupled toa bronchoscope 20 working channel or a catheter 430 or similar deliverydevice which is advanceable through a lumen in the bronchoscope 20. Thedevice 400 is constrained within the catheter 430 to allow for ease ofadvancement through the bronchoscope. The device 400 remains within thecatheter 430 until the distal tip of the catheter 430 is desirablypositioned within the lung L. Alternatively, a guidewire 313 may be usedto guide the catheter 430 through and distal to the bronchoscope 20 toan optimal position within the lung L before the introducer 220 iscoupled to it.

As illustrated in FIG. 102 , the distal tip of the catheter 430 isadvanced beyond the distal tip of the bronchoscope 20. This allows thecatheter 430 to reach locations that are beyond the reach of thebronchoscope 20 due to size constraints (i.e. the smaller diameter ofthe catheter 430 can pass through small diameter or contortedpassageways that the larger diameter bronchoscope is restricted fromentering). Thus, in some instances, the catheter 430 is able to reachfar distal portions of the lung L, such as the apical portions of theupper lobes and the lateral corners of the lower lobes, which aretypically unreachable by the bronchoscope alone.

Once the distal tip of the catheter 430 is positioned near a targetlocation for placement of the treatment device 400, the device 400 isdeployed. Deployment from the catheter 430 may be achieved by a varietyof methods or a combination of multiple methods. In this embodiment, thedevice 400 is pushed beyond the catheter 430, such as with the use ofthe torqueing tool 408, to allow the tissue gathering element 402 bendtoward its pre-formed or natural configuration (e.g. radially outwardlyand around into a loop shape as illustrated in FIG. 102 ). In thisembodiment, the tissue gathering element 402 has a distal tip 405 havinga free end 902 shaped as an elongate taper ending in a ball 914. Thus,deployment allows the distal tip of the tissue gathering element 402 toengage the surrounding tissue, curving through and/or against thetissue. Such deployment may be in an airway or beyond the naturalairways into damaged tissue, parenchyma, alveoli, artificially createdpassageways, disease created passageways or other types of lung tissue.

The device 400 is then rotated by applying torqueing, twisting orrotational force to at least a portion of the device 400 with the use ofthe torqueing tool 408. As shown, the torqueing tool 408 includes ahandle which is graspable by a user so as to manually applying therotational force. Since the torqueing tool 408 is attached to the device400, the device 400 (and therefore tissue gathering element 402) rotatesas well. This gathers up the surrounding lung tissue onto and around thetissue gathering element 402 as the element 402 rotates. Thus, looseparenchyma, portions of blebs and bullae, damaged alveolar sacs andother distended, slackened or stretched tissue is pulled inwardly,twisted and/or gathered up by the tissue gathering element 402. Rotationcontinues, gathering the loose, slackened tissue, until desired tensionis achieved in the tissue.

It may be appreciated that although such rotation is applied around thelongitudinal axis 411, such rotation may occur in the tissue aroundother axes. Such other axes may be at a variety of angles to thelongitudinal axis 411 and on either side of the longitudinal axis. Thismay occur due to bending of portions of the device 400, such as bendingof the tissue gathering element 402, during advancement of the tissuegathering element 402 or during rotation itself. Such bending may causethe torque applied around the longitudinal axis 411 to be transmittedaround one or more different axes. Such other axes are typically in therange of 1 to 90 degrees from the longitudinal axis 411.

It may be appreciated that the desired amount of torque imposed by thedevice may vary depending on the patient anatomy and disease state, toname a few. In some embodiments, the desired level of torque isdetermined by tactile feedback to the user. For example, in someinstances, torque is applied until the user encounters desiredresistance to rotation, ranging from minimal resistance to completeobstruction of further rotation. Such resistance may simply be felt bythe user as manual rotation is attempted. Typically, torque is appliedquite easily while slack tissue is gathered until a sudden increase intension is reached. In some patients, a minimal amount of tension isdesired wherein torque application is ceased as soon as the increase intension is reached. In other embodiments, torque is measured by a torquemeasurement mechanism, such as a torque sensor, torque transducer ortorque meter attached to or incorporated within the torqueing tool 408.In some instances, torque sensors or torque transducers use straingauges applied to a rotating shaft. With this method, a mechanism topower a strain gauge bridge is present as well as a means to receive thesignal from the rotating shaft. This can be accomplished using sliprings, wireless telemetry, or rotary transformers, to name a few. Insome embodiments, SAW devices are attached to the shaft and remotelyinterrogated. The strain on these tiny devices as the shaft flexes areread remotely and output without the need for attached electronics onthe shaft. In other embodiments, torque is measured by way of twistangle measurement or phase shift measurement, whereby the angle of twistresulting from applied torque is measured by using two angular positionsensors and measuring the phase angle between them. In some embodiments,a predetermined level of torque is established wherein the torquemeasurement mechanism indicates when the predetermined level of torquehas been reached, such as by a visual or auditory signal or byobstruction of further rotation. In some embodiments, the predeterminedamount of torque is approximately 0 to 3 in-oz, preferably approximately0.1 to 0.5 in-oz, more preferably approximately 0.1 to 0.3 in-oz.

In other embodiments, torque is applied until a predetermined amount ofrotation has been achieved. In some instances, the amount of rotation isvisually monitored such as by watching rotation of the tissue gatheringelement 402 by visualization with a variety of methods, includingfluoroscopy and/or imaging through a bronchoscope camera. Typically,when the desired amount of rotation is observed, the user ceasesrotation. In other instances, the amount of rotation is measured by arotational measurement mechanism, such as attached to or incorporatedwithin the torqueing tool 408. In some embodiments, a predeterminedamount of rotation is established wherein the rotation measurementmechanism indicates when the predetermined level of rotation has beenreached, such as by a visual or auditory signal or by obstruction offurther rotation. In some embodiments, the predetermined amount ofrotation is up to 10 degrees, up to 20 degrees, up to 30 degrees, up to40 degrees, up to 45 degrees, up to 50 degrees, up to 60 degrees, up to70 degrees, up to 80 degrees, up to 90 degrees, up to 100 degrees, up to110 degrees, up to 120 degrees, up to 130 degrees, up to 135 degrees, upto 140 degrees, up to 150 degrees, up to 160 degrees, up to 170 degrees,up to 180 degrees, up to 225 degrees, up to 270 degrees, up to 315degrees, up to 360 degrees, or over 360 degrees.

Once the lung L is desirably re-tensioned, the device 400 is anchored tomaintain the rotated arrangement. This is achieved by deployment of theanchoring element 404. FIG. 103 illustrates such deployment. Here thecatheter 430 is retracted to expose the anchoring element 404. Here, thetether 702 is still attached to proximal end of the device 400,particularly to the anchoring element 404, and holds the anchoringelement 404 in a stretched configuration. The anchoring element 404 isthen expanded, such as by advancement of the tether 702 in relation tothe torqueing tool 408. Alternatively, or in addition, the torqueingtool 408 may be retracted. This assists in shortening the anchoringelement 404, allowing the coils to reform as illustrated in FIG. 104 .It may be appreciated that anchoring may be verified by observation ofany unwinding of the device 400. Typically, any unwinding of the device400 pulls on the airway until the airway is unable to rotate anyfurther. Thus, anchoring is established.

The device 400 is then released, as illustrated in FIG. 105 . Thetorqueing tool 408 is released from the device 400 by removal of thehitch wire 727. Removal of the hitch wire 727 allows the hooked end 722the torqueing tool 408 withdraw from the attachment feature 610.Likewise, the tether 702 is removed from the anchoring element 404. Thetools (torqueing tool 408, hitch wire 727, tether 702) are then removedand the device 400 is left behind as an implant.

Patients suffering from severe COPD typically have a high chance ofhaving an inflammatory response to implantation of the device 400. Insuch instances, the inflammatory response can be beneficial toimplantation since it typically causes higher volume contraction, lungvolume reduction and lung tensioning. For such patients, a lower levelof torque may be applied in anticipation of the effects of theinflammatory response.

It may be appreciated that in some embodiments, a similar inflammatoryresponse is actively induced in a patient so as to obtain similarbenefits. In some embodiments, the tissue gathering element 402, orother portions of the device 400, includes sharp edges which cause afibrotic reaction or thickening of the tissue. This in turn causesincreased contraction. In other embodiments, fibrosis is achieved byincreasing tissue tension because the wound healing and the formation ofscar tissue is accelerated. In some embodiments, the tissue gatheringelement 402, or other portions of the device 400, are texturized toenhance epithelium adhesion and fibrotic reaction around the implanteddevice 400. For example, in some embodiments, the device 400 istexturized by etching lines along its surface, such as lines that arespaced 2-30 micrometers apart to help drive macrophage propulsion alongthe surface and to preserve macrophage health that minimizes collateraltissue growth formations that may occur in the airway. It may beappreciated that the tissue gathering element 402, or other portions ofthe device 400, may be coated to reduce infection. Examples of coatinginclude silver plating, which is known to inhibit bacteria. Othercoatings, coverings or plating materials may be applied to the device toinhibit colonization of bacteria, inhibit growth of granulation tissue,random collagen or other foreign growths that would compromisebreathing. Coatings, coverings or plating materials may be provided toenhance epithelium attachment and health, cause fibrosis formation toenhance the structure of the emphysema lung tissue and to reducefriction between the device and delivery system components duringdelivery into the patient. It may be appreciated that any reduction ofcoating over time may be inconsequential since it may be most desiredduring and shortly after implantation.

In some embodiments, natural and/or induced inflammatory and woundhealing responses are controlled with the use of agents, such assteroidal drugs. Coatings may be applied to the device to efficientlycarry anti-inflammatory drugs to the lung airway in the form of a gelthat rubs into the airway wall or lung tissue, in the form of aresorbable polymer that releases the drugs over time or in the form offilm on the surface of the device. These drugs may include, for example,Sirolimus, Rapamune, Rapamycin, Paclitaxel, Taxol or a combinationthereof. In some instances, such control may allow for more precisetreatments, such as more precise levels of torque application dependingon patient condition and anatomy.

In some embodiments, various therapies are used in combination withimplantation of one or more devices 400. For example, in some instances,radiotherapy is used in combination with implantation of one or moredevices 400. Radiotherapy or X-ray therapy cross-links and shrinks lungtissue so as to cause additional tissue contraction, tensioning the lungtissue which adds more elastic recoil and reduced compliance.

It may be appreciated that the methods, devices and systems providedherein may be used in combination with a variety of conventionaltreatments for COPD and other lung conditions. For example, in someinstances, the methods, devices and systems provided herein may be usedin combination with lung volume reduction surgery (LVRS). Likewise, insome instances, the methods, devices and systems provided herein may beused in combination with conventional implantable therapeutic devices,such as conventional endobronchial valves and conventional endobronchialcoils. Example conventional endobronchial valves include those developedby Emphasys Medical (now Pulmonx-Redwood City, Calif.) as a minimallyinvasive alternative to lung volume reduction surgery for emphysema.Emphasys was purchased by Pulmonx in 2009, and Pulmonx currently marketsthe Zephyr® endobronchial valve (developed by Emphasys). Other exampleconventional endobronchial valves include those developed by Spiration(Seattle, Wash.) which was acquired by Olympus in 2010. Exampleconventional endobronchial coils include those developed by PnemRx(Mountain View, Calif.) which has been acquired by BTG. Based in London,BTG is an international specialist healthcare company that is active ininterventional medicine and specialty pharmaceuticals. BTG has sincebeen acquired by Boston Scientific.

Likewise, the methods, devices and systems provided herein may be usedin combination with conventional lung airway bypass products that causeventing of trapped air, such as conventional pulmonary stents. Exampleconventional pulmonary stents include the Ultraflex™ Tracheobronchial

Stent System (Boston Scientific), the Polyflex™ Self-Expanding SiliconeAirway Stent (Boston Scientific) and the Dynamic™ (Y) Stent BifurcatedTracheobronchial Stent (Boston Scientific).

Likewise, the methods, devices and systems provided herein may be usedin combination with conventional devices that inject steam to causetissue trauma, scarring and cell death, such as the InterVapor®Bronchoscopic Thermal Vapor Ablation (BTVA®) system which has returnedto the market after a brief hiatus as the asset sale of Uptake MedicalCorporation was being completed to Broncus Holding Co. A new company,Uptake Medical Technology, Inc was formed in Seattle, Wash., USA and hasreceived a new CE Mark for the technology. Likewise, the methods,devices and systems provided herein may be used in combination withconventional sealants, such as the AeriSeal® System. The AeriSeal®System is foam-based lung sealant system wherein polymers are mixed andblown with air to create foam in the damaged regions of lung. The foamturns to a state like hard rubber blocking holes and damages in the lungand stays for several months while the lung shrinks in its normal size.The AeriSeal® System was developed by Aeris Therapeutics and was lateracquired by Pulmonx®.

Clip Treatment Overview

In some instances, lung function may be improved by straighteningairways at bifurcations or other branching locations within the lung.This is achieved by pulling the airways closer together along a lengthof the airways thereby creating a straightened flow path. In someembodiments, this is achieved with the use of one or more pulmonarytreatment devices 10 having the form of a clip.

FIG. 106 illustrates an embodiment of such a pulmonary treatment device10 of the present invention. In this embodiment, the device 10 comprisesa clip 1000 having a first arm 1002 a and a second arm 1002 b, eachhaving a free end with a respective tip 1004 a, 1004 b, such as anatraumatic tip. In this embodiment, the arms 1004 a, 1004 b are disposedsubstantially parallel when in a resting position so that the tips 1004a, 1004 b are adjacent to each other. It may be appreciated that theclip 1000 may have greater than two arms 1002, such as three, four,five, or six arms, to name a few; however, clips 1000 having two arms1002 will be depicted herein for simplicity. The features of the clips1000 having greater than two aims may be extrapolated from theseexamples.

It may be appreciated that the clip 1000 may be comprised of anybiocompatible material that can withstand conditions in an airway, suchas metals, steels, titaniums, nitinols, plastics, or ceramics to name afew. The arms 1002 a, 1002 b can have a variety of forms, such as tube,wire, ribbon, sheet, machined, extruded or drawn, to name a few.Likewise, the arms 1002 a, 1002 b can be covered in a variety ofmaterials, such as cloth, polytetrafluoroethylene (PTFE), or expandedpolytetrafluoroethylene (ePTFE), to name a few. In some embodiments, thearms 1002 a, 1002 b are formed from a single shaft 1006 that is benttherebetween, as shown, thus forming a proximal end 1008 of the clip1000 that is curved. In other embodiments, the clip 1000 has differingform and construction as will be described in later sections. In thisembodiment, the arms 1002 a, 1002 b are of differing length. This mayassist in placement wherein the longer arm is directed into positionfirst, followed by the shorter arm. This allows attention to be focusedon a single arm at a time during the initial directing phase of theplacement. Once an arm has entered an airway it will typically naturallyfollow the airway.

FIGS. 107A-107C illustrate an embodiment of the clip 1000 of FIG. 106 inuse. Referring to FIG. 107A, the clip 1000 is loaded into a deliverydevice 1010 (e.g. catheter, endoscope, bronchoscope, etc) having adistal end 1012 from which it is delivered. In this embodiment, the clip1000 is loaded into the delivery device 1010 so that the tips 1004 a,1004 b face distally and are first to emerge from the distal end 1012upon deployment. In this embodiment, the clip 1000 is not in aconstrained position while within the delivery device 1010, however, itmay be appreciated that other clip 1000 embodiments may be constrainedtherein. In some embodiments, the clip 1000 is configured to be loadedwithin and advanceable through a 1.3-3.2 mm channel within the deliverydevice 1010 or through a 1-10 French catheter.

The delivery device 1010 is advanced through the bronchial tree to atarget location, such as an ostium OS which branches into a first airwayAW1 and a second airway AW2. In this embodiment, the first airway AW1and second airway AW2 are excessively diverging away from each otherprior to treatment. This is because the tissue is distended so lungelastic recoil has been lost in the lung. The native airways are themost robust structures in the lung and they naturally diverge, so it isdesired to return the airways to their natural state. The clip 1000brings the airways AW1, AW2 closer together to cause lung volumereduction and enhanced treatment durability. The clip 1000 is advancedfrom the distal end 1012 of the delivery device 1010 by advancement of adeployment device 1014 which acts as a pusher or plunger. The deploymentdevice 1014 may have a variety of forms, including a high torque tube,braided tube, rope, wire, rod, element tube, etc. The clip 1000 isdeployed so that the first arm 1002 a enters the first airway AW1 andthe second arm 1002 b enters the second airway AW2. Since, in thisembodiment, the first arm 1002 a is slightly longer then the second arm1002 b, the first arm 1002 a will enter first, however the arms 1002 a,1002 b typically enter the airways substantially simultaneously. In thisembodiment, the clip 1000 is advanced so that the proximal end 1008resides substantially near the wall W that connects the airways AW1,AW2, as illustrated in FIG. 107B. Due to the rigidity of the clip 1000the arms 1002 a, 1002 b recoil toward each other, pushing the innerwalls of the diverging airways AW1, AW2 toward each other, therebystraightening the airways AW1, AW2 in the vicinity. This is also shownin FIG. 107C which provides a larger overall view of the anatomy with anembodiment of the clip 1000 in place. Here, the clip 1000 is shownpositioned so that the first arm 1002 a enters the first airway AW1 andthe second arm 1002 b enters the second airway AW2. In this embodiment,the clip 1000 is advanced so that the proximal end 1008 residessubstantially near the wall W that connects the airways AW1, AW2.Advancement of the clip 1000 draws two or more airways together to causecompression between them. By causing this lung volume reduction, thegreater lung is tensioned and lung elastic recoil is restored.

It may be appreciated that the clip 1000 may be removed if desired. Forexample, the proximal end 1008 can be accessed and grasped, such as withforceps or a suitable tool. The proximal end 1008 can then be pulled inthe proximal direction to withdraw the arms 1002 a, 1002 b from theairways AW1, AW2. The atraumatic tips 1004 a, 1004 b simply slide alongthe walls of the airways until they disengage from the airways. The clip1000 can then be withdrawn from the body. Optionally, the clip 1000 canbe repositioned in a similar manner. For example, the clip 1000 can beentirely removed from the airways and then reapplied while still nearthe target location, or the clip 1000 can be repositioned along theairways while the clip 1000 is at least partially engaged with one ormore airways. This may entail pushing, pulling, raising, lowering,tilting or otherwise manipulating the clip 1000.

In some embodiments, one or more clips 1000 are used to treat a targetlocation having a plurality of airways branching from an ostium OS. FIG.108 illustrates a target location comprising a first airway AW1, asecond airway AW2 and a third airway AW3, all branching from a singleostium OS and diverging away from each other. Here, three clips 1000 aredeployed and positioned as follows. First, a first clip 1000′ ispositioned in a manner similar to FIGS. 107A-107C, wherein the first arm1002 a′ of the first clip 1000′ enters the first airway AW1 and thesecond arm 1002 b′ of the first clip 1000′ enters the second airway AW2.In this embodiment, the first clip 1000′ is advanced so that itsproximal end 1008′ resides substantially near the wall W′ that connectsthe first and second airways AW1, AW2. Due to the rigidity of the firstclip 1000′ the arms 1002 a′, 1002 b′ recoil toward each other, pushingthe inner walls of the diverging airways AW1, AW2 toward each other(indicated by arrows), thereby straightening the airways AW1, AW2 in thevicinity. Second, a second clip 1000″ is positioned in a manner similarto FIGS. 107A-107C, wherein the first arm 1002 a″ of the second clip1000″ enters the second airway AW2 and the second arm 1002 b″ of thesecond clip 1000″ enters the third airway AW3. In this embodiment, thesecond clip 1000″ is advanced so that its proximal end 1008″ residessubstantially near the wall W″ that connects the second and thirdairways AW2, AW3. Due to the rigidity of the second clip 1000″, the arms1002 a″, 1002 b″ recoil toward each other, pushing the inner walls ofthe diverging airways AW2, AW3 toward each other (indicated by arrows),thereby straightening the airways AW2, AW3 in the vicinity. In someembodiments, a third clip 1000′″ is applied to reduce strain on thesecond airway AW2, reinforce the compression of the walls W′,W″ andmaintain straightening of the airways AW1, AW2, AW3. As illustrated, theclip 1000′″ is positioned so that the first arm 1002 a′″ of the thirdclip 1000′″ enters the first airway AW1 and the second arm 1002 b″ ofthe third clip 1000′″ enters the third airway AW3. In this embodiment,the third clip 1000′″ is advanced so that its proximal end 1008′″resides substantially near the walls W′, W″ that connects the airways.Due to the rigidity of the third clip 1000′″, the arms 1002 a′″, 1002 b″recoil toward each other, pushing the inner walls of the first and thirdairways AW1, AW3 toward each other, thereby reducing strain on thesecond airway AW2, reinforcing the compression of the walls W′,W″ andmaintaining straightening of the airways AW1, AW2, AW3.

In some embodiments, the airways AW1, AW2, AW3 reside in a trianglepattern rather than substantially along the same plane. For example, thesecond airway AW2 may reside at an angle tipping away from a planewithin which the first and third airways AW1, AW3 reside. In suchembodiments, the clips 1000′, 1000″, 1000′″ may be placed similarly toFIG. 108 , however the resulting compressing is a three dimensionalcompression. The volume within the triangular or pyramid shape (e.g.from the ostium OS outwardly in a distal direction) is compressed. Byplacing many clips at various angles and orientations within the lung, alarger volume can be compressed while still allowing gas to flow bothways. This allows functional lung tissue to still exchange gas.

FIG. 109 illustrates this concept by treating a plurality of targetlocations within a lung L wherein each target location comprises atriple branching airway from a single ostium. Here, three targetlocations t1, t2, t3 are shown as indicated by dashed circled outline.As shown, each target location t1, t2, t3 has a triple branching airwayfrom a single ostium. Likewise, in this embodiment, three clips 1000′,1000″, 1000′″ are positioned at each target location according to FIG.108 . As shown, the three target locations t1, t2, t3 are accessiblefrom a more proximal ostium. Therefore, a delivery device 1010 may beused to access each target location t1, t2, t3 from the same main branchleading thereto. Once the clips are placed, compression is achievedthroughout the lung L (as indicated by arrows), raising the diaphragmand restoring airflow.

It may be appreciated that the clips 1000 may take a variety of formsand include a variety of features. As mentioned previously, in someembodiments, the arms 1002 a, 1002 b of the clip 1000 are formed from asingle shaft 1006 that is bent therebetween, thus forming a proximal end1008 of the clip 1000 that is curved. In some embodiments, the proximalend 1008 may include additional curves, bends or loops to impartparticular features. For example, FIG. 110 illustrates an embodiment ofa clip 1000 having a proximal end 1008 that includes a strain relievingloop. FIG. 111 illustrates another embodiment of a clip 1000 having aproximal end 1008 that includes a strain relieving loop. However, inthis embodiment, the arms 1002 a, 1002 b are curved rather thanstraight. In particular, the arms 1002 a, 1002 b curve outwardly from alongitudinal axis 1015 that extends through the proximal end 1008 andthen curve inwardly toward the longitudinal axis 1015 near the tips 1004a, 1004 b, thereby creating a bulge. Such curvature of the arms 1002 a,1002 b may be beneficial in particular situations, such as whencompression of tissue or pulling of airways is desired at a locationmore distally from the proximal end 1008. Thus, a gap 1016 is providedbetween the proximal end 1008 and the force bearing surfaces (i.e.between the gaps and the tips 1004 a, 1004 b) of the arms 1002 a, 1002b. This may be useful in a variety of situations. For example, FIGS.112A-112B illustrate a branched airway having an entwined blood vesselBV. Such entwinement is often common. FIG. 112B illustrates anembodiment of a clip 1000 having a gap 1016 similar to the clip 1000 ofFIG. 111 . Thus, the clip 1000 is positioned so that a first arm 1002 aenters a first airway AW1 and a second arm 1002 b enters a second airwayAW2 while the proximal end 1008 remains in the ostium OS. The bulge ofthe arms 1002 a, 1002 b creating the gap 1016 avoids pinching of theblood vessels BV which reside adjacent the ostium OS. Likewise, theforce bearing surfaces of the arms 1002 a, 1002 b (which reside alongthe longitudinal axis 1015) are positionable further away from theostium OS where the airways AW1, AW2 are more easily moved. At this moredistal location, the airways AW1, AW2 may be drawn together a greaterdistance to create more compression of tissue and therefore more tensionin the lung. Further, by oversizing the bulge, the walls of the ostiumOS (and adjacent collagen and cartilage reinforced airways) may push thearms 1002 a, 1002 b into compression creating increased force.

It may be appreciated that the embodiment of the clip 1000 illustratedin FIG. 112B has a proximal end 1008 having the shape of a U-bend. TheU-bend comprises a narrowed loop section that, in some instances,reduces strain and stress on the clip 1000 while loaded in the deliverydevice 1010.

Likewise, the U-bend provides an identifiable location upon which tograsp for easy removal if so desired. Further, when combined with bulgedarms, the bulged arms keep the clip 1000 from being excessively spreadat the U-bend. It may be appreciated that the U-bend may be present in avariety of variations such as a V-bend, W-bend or other types of bends.

It may be appreciated that the clip 1000 may have a variety of shapesand sizes. The arms 1002 a, 1002 b may be symmetrical ornon-symmetrical, of similar or differing length, of similar or differingcross-section, straight or curved, constructed of same or differingmaterial, to name a few. Likewise, the arms 1002 a, 1002 b may be formedindividually and joined together, either directly to each other (such asby bonding, e.g. metallurgical joining, welding, adhering, gluing) or toan intervening structure such as a connector. Or, the arms 1002 a, 1002b may be formed from a continuous structure, such as described above.The arms 1002 a, 1002 b may have consistent or differing cross-section.FIG. 113 illustrates an embodiment of a clip 1000 having arms 1002 a,1002 b with a variety of curves, some of which are symmetrical about alongitudinal axis 1015 and some of which are not. Here, the clip 1000comprises a proximal end 1008 having a hoop or loop shape. Each arm 1002a, 1002 b extends distally therefrom in a repetitive pattern (mirroringeach other)—first bulging outwardly away from the longitudinal axis 1015and then curving inwardly toward the longitudinal axis 1015-creatingcontact points 1020 along the longitudinal axis 1015. These contactpoints 1020 are separated by a distance d along the longitudinal axis1015. The distance d between each of the contact points 1020 may be thesame or may vary. By spacing the contact points 1020 farther apart, theclip 1000 is stronger and by spacing them closer together, the clip 1000can be made to be more flexible. In preferred embodiments, the proximalend 1008 having the U-bend is strong and the distal free ends areflexible. In this embodiment, the aforementioned repetitive pattern endsnear the tips 1004 a, 1004 b wherein the arms 1002 a, 1002 b then curvein a nesting arrangement. Thus, where the first arm 1002 a bends towardthe longitudinal axis 1015, the second arm 1002 b bends away from thelongitudinal axis 1015. Therefore, in this region, the arms 1002 a, 1002b follow the shape of each other (nesting against each other) so as tocreate additional contact surface area. By nesting, the tissue contactis continuous and smooth. This may eliminate pinch points that canpotentially pinch off blood vessels or tissue circulation.

It may be appreciated that the clip 1000, particularly the arms 1002 a,1002 b may be coated, covered, jacketed, treated or otherwise surfacemodified so as to create beneficial results, such as increased grippingstrength. For example, in some embodiments one or more portions of theclip 1000 covered with a metal or polymer structure (e.g. coil, weave,etc.). Optionally, one or more portions of the clip 1000 may be coatedwith or covered by a drug eluting substance or polymer, such as toreduce inflammation or to kill bacteria.

In some embodiments, the clip 1000 includes one or more magnets toincrease gripping strength. Such magnets may be incorporated into acover or jacket, or such magnets may be constructed in the arms 1002 a,1002 b (or other portions of the clip 1000) themselves. FIG. 114illustrates an embodiment of a clip 1000 having magnets. In thisembodiment, a series of magnets 1030 are positioned along a first arm1002 a and a coordinating series of magnets 1030′ are positioned along asecond arm 1002 b. Typically, the magnets 1030 and their coordinatingmagnets 1030′ are disposed directly opposite each other so as to drawthe magnets 1030, 1030′ toward each other, however it may be appreciatedthat magnetic force may be varied by placement of the magnets 1030,1030′, type of magnets and size of magnets, to name a few. Positioningof the clip 1000 having magnets 1030, 1030′ so that the first arm 1002 ais within a first airway AW1 and the second arm 1002 b is within asecond airway AW2, as illustrated in FIG. 114 ) allows the magnets 1030,1030′ to naturally draw the arms 1002 a, 1002 b toward each other bymagnetic force. First, the closest magnets 1030, 1030′ are drawntogether which then disposes the next closest magnets 1030, 1030′ to bedrawn together and so forth in a zipper fashion. As the arms 1002 a,1002 b move closer together, the magnetic force increases (exponentiallywith reduced distance) until the maximum compression of the tissuetherebetween occurs. During breathing, the distance between the magnets1030, 1030′ may vary, however, the magnetic force will then resume itsresting arrangement. Magnets provide a beneficial result due to theirability to provide more force than many other mechanical solutions andthey can be easily removed.

As mentioned previously, the clips 1000 typically include a first arm1002 a and a second arm 1002 b, each having a free end with a respectivetip 1004 a, 1004 b, such as an atraumatic (e.g. blunt) or traumatic(e.g. pointed) tip. In some embodiments, the tip (e.g. tip 1004 a) isaligned with its respective arm (e.g. arm 1002 a). In other embodiments,such as depicted in FIGS. 115-116 , the tips 1004 a, 1004 b are locatedon a portion of their respective arms 1002 a, 1002 b which bend radiallyoutward. In these embodiments, the arms 1002 a, 1002 b bulge away from alongitudinal axis 1015 throughout the gap 1016 and then bend toward thelongitudinal axis 1015 and each other in the distal direction creatingan area of contact and compression of tissue therebetween. Moredistally, arms 1002 a, 1002 b then bend away from the longitudinal axis1015, such as at a downward angle, as shown so that the tips 1004 a,1004 b are facing radially outward. Such angling allows the arms 1002 a,1002 b to slide along the most inward walls of a bifurcated airway whilethe tips 1004 a, 1004 b prevent retraction. Such resistance may betraumatic, such as in FIG. 115 wherein the tips 1004 a, 1004 b arepointed, or atraumatic, such as in FIG. 116 wherein the tips 1004 a,1004 b are blunt. In FIG. 116 , the tips 1004 a, 1004 b are springloaded for strain relief

FIGS. 117-118 illustrate an embodiment of a clip 1000 having proximalfacing tips 1004 a, 1004 b positioned within a bifurcation. Inparticular, FIG. 117 illustrates the embodiment of the clip 1000 beingdelivered with the use of a delivery device 1010. Here, the distal tips1004 a, 1004 b have been deployed from the distal end 1012 of thedelivery device 1010, wherein a first arm 1002 a is entering a firstairway AW1 and a second arm 1002 b is entering a second airway AW2, byadvancement of a deployment device 1014 (e.g. pusher or plunger). Thetips 1004 a, 1004 b are advanced along the airways AW1, AW2 engaging thewalls as shown. Due to the strength of the arms 1002 a, 1002 b, thewalls may bend at the areas of engagement creating points of purchase.Thus, retraction of the clip 1000 is resisted due to the points ofpurchase. However, in some embodiments, this resistance may be overcomewith sufficient force. FIG. 117 illustrates a tether 1040 extendingproximally from the delivery device 1010, wherein the tether 1040 isattached to the proximal end 1008 of the clip 1000 so as to allow suchretraction of the clip 1000. FIG. 118 illustrates the clip 1000 of FIG.117 fully deployed within the bifurcation. As shown, the first airwayAW1 and the second airway AW2 are drawn together due to the recoil forceof the arms 1002 a, 1002 b toward each other. Typically, the arms 1002a, 1002 b are comprised of materials that can store strain energy, suchas spring steel. The clip 1000 resists slipping out of position due tothe frictional force of the tips 1004 a, 1004 b applying purchase to theairway walls. In some embodiments, the arms 1002 a, 1002 b areconstructed so as to buckle or flip if sufficient force is applied inthe proximal direction (i.e. causing the arms 1002 a, 1002 b toessentially straighten). This allows the clip 1000 to be removed whileminimizing any trauma to the lung tissue.

It may be appreciated that each of the arms 1002 of the clip 1000 mayhave differing shapes, including irregular shapes or compoundcurvatures. For example, FIGS. 119-121 illustrate embodiments of clips1000 wherein the arms 1002 a, 1002 b have differing lengths and/orshapes from each other. Referring to FIG. 119 , the clip 1000 has afirst arm 1002 a which is longer than the second arm 1002 b. Further,the first arm 1002 a has a shape formed by curving radially outwardlyfrom the longitudinal axis 1015 and forming a first curvature 1050, asecond curvature 1052 and then a third curvature 1054. The firstcurvature 1050 has an arc shape which then transitions into an inversearc shape for the second curvature 1052. This then transitions into asemi-circle or arch shape which directs the distal tip 1004 a toward thelongitudinal axis 1015. This compound curvature (combination ofcurvatures 1050, 1052, 1054) creates a hook shape which may be used forgathering diseased tissue (e.g. loose tissue), such as in a twistingfashion and a pulling fashion. The partial loop shape extending radiallyoutwardly from the longitudinal axis 1015 may assist in gathering tissueduring torqueing, as described previously. However, it may beappreciated that the compound curvature may be used for other purposeswithout twisting, torqueing or pulling. It may be appreciated that thehooking shape (distal tip 1004 a facing the longitudinal axis 1015) mayassist in holding tissue or creating purchase when pulling the clip 1000in the proximal direction, such as along the longitudinal axis 1015. Inthis embodiment, the second arm 1002 b curves radially outwardly fromthe longitudinal axis 1015 in a direction opposite the first arm 1002 a.Again, a hooking shape is formed (distal tip 1004 b facing thelongitudinal axis 1015). Still, the arms 1002 a, 1002 b are constructedso as to compress tissue positioned between the arms 1002 a, 1002 bthereby straightening the airways as described above.

It may also be appreciated that the arms 1002 may have a variety ofother shapes, including bends and arcs which are rounded or angular, inthe same direction or opposite directions, and in a variety ofconfigurations. FIG. 120 illustrates a clip 1000 similar to thatillustrated in FIG. 111 but with an extended first arm 1002 a. Here, thefirst arm 1002 a comprises a partial loop which curves radiallyoutwardly from the longitudinal axis 1015 and extends such that the tip1004 a is directed back toward the longitudinal axis 1015. In otherembodiments, the distal tip 1004 a is directed substantially parallel tothe longitudinal axis 1015 in the distal direction, such as extendingaround a full circle. In such embodiments, the loop may be described ashaving a radius R. Such a loop shape may serve a variety of purposes. Insome instances, the loop functions creates a hook shape which may beused for gathering diseased tissue (e.g. loose tissue), such as in atwisting fashion and a pulling fashion. The partial loop shape extendingradially outwardly from the longitudinal axis 1015 may assist ingathering tissue during torqueing, as described previously. However, itmay be appreciated that the partial loop shape may be used for otherpurposes without twisting, torqueing or pulling. It may be appreciatedthat the hooking or loop shape (distal tip 1004 a facing thelongitudinal axis 1015) may assist in holding tissue or creatingpurchase when pulling the clip 1000 in the proximal direction, such asalong the longitudinal axis 1015. Still, the arms 1002 a, 1002 b areconstructed so as to compress tissue positioned between the arms 1002 a,1002 b thereby straightening the airways as described above.

FIG. 121 illustrates another embodiment of a clip 1000 having anextended first arm 1002 a with a shape differing from its second arm1002 b. Here, the arms 1002 a, 1002 b are joined at the proximal end1008. In this embodiment, the first arm 1002 a extends in a firstdirection from the proximal end 1008 and then bends laterally outwardlyin a second direction to form a circular, inwardly spiraled shape. Inthis embodiment, the second arm 1002 b extends from the proximal end1008 generally along a longitudinal axis 1015 but has a shorter lengththan the first arm 1002 a. FIG. 121 illustrates the second arm 1002 bbowed outwardly, away from the longitudinal axis 1015 as it would appearwhen implanted. However, it may be appreciated the arms 1002 a, 1002 bare configured recoil toward each other, compressing tissuetherebetween.

This is illustrated in FIG. 122 wherein the clip 1000 of FIG. 121 isshown positioned at a bifurcation. In some instances, the inwardlyspiraled shape of the first arm 1002 a may be used for gatheringdiseased tissue (e.g. loose tissue), such as in a twisting fashion and apulling fashion. The spiral shape may assist in gathering tissue duringtorqueing, as described previously. However, it may be appreciated thatthe spiral shape may be used for other purposes without twisting,torqueing or pulling. It may be appreciated that the spiral shape mayassist in holding tissue or creating purchase when pulling the clip 1000in the proximal direction, such as along the longitudinal axis 1015.Still, the arms 1002 a, 1002 b are constructed so as to compress tissuepositioned between the arms 1002 a, 1002 b thereby straightening theairways as described above.

In some embodiments, the delivery device 1010 is configured to rotatethe clip 1000 during its delivery to assist in positioning the arms 1002into the airways. FIG. 123 illustrates an embodiment of a deliverydevice 1010 having a deployment device 1014 that is coupleable to theclip 1000 in a manner that allows transmission of torque to the clip1000 by rotation of the deployment device 1014. FIG. 124 provides aclose-up view of an embodiment of such a deployment device 1014. In thisembodiment, the deployment device 1014 has a blunt distal end 1060. Inthis embodiment the blunt distal end 1060 is closed, however it may beappreciated that it may alternatively be open to allow passage of toolsor instruments therethrough. In this embodiment, the deployment device1014 includes an indent, slot or window 1062 having a top edge 1064 anda bottom edge 1066. In this embodiment, the window 1062 has a flatbottom edge 1066. This provides a flat surface to apply direct force tothe clip 1000 during advancement of the deployment device 1014. In thisembodiment, the window 1062 has a slanted top edge 1064. This allows theclip 1000 to slide out of the window 1062 when the deployment device1014 is retracted. However, the clip 1000 can be held within the window1062 with the use of a hitch wire 1068 which is advanceable at leastpartially through the deployment device 1014 so as to cross through thewindow 1062, holding the proximal end 1008 of the clip 1000 within thewindow 1062, as depicted in FIG. 124 . Retraction of the hitch wire 1068allows the proximal end 1008 of the clip 1000 to slide along the slantedtop edge 1064 and out of the window 1062. This is desired when the clip1000 is released for implantation. It may be appreciated that the window1062 may have a variety of shapes. In some embodiments the window 1062has a slanted bottom edge 1066. This may assist in holding the proximalend 1008 of the clip 1000 in place during rotation. FIG. 125 illustratesan embodiment of a window 1062 having a spiral shape. This allows theclip 1000 to remain captured in the window 1062 when the deploymentdevice 1014 is loaded in rotation but releases the clip 1000 whencounter-rotation is applied. Thus, the window 1062 can be locking inclockwise rotation and releasing in counter-clockwise rotation or viceversa.

FIG. 126 illustrates an embodiment of a deployment device 1014 similarto FIG. 124 , however here the hitch wire 1068 has a configured proximalend 1070 and distal end 1072. In this embodiment, the distal end 1072has a loop shape which provides a blunt tip and is sized to resistretraction into the deployment device 1014. In such embodiments, thehitch wire 1068 is comprised of a compliant material which is able toplastically or elastically deform in shape to allow the distal end 1072to be retracted into the deployment device 1014 with sufficient positiveload in the proximal direction. This assists in avoiding accidentalwithdrawal of the hitch wire 1068 and release of the clip 1000.Continued pulling of the hitch wire 1068 in the proximal direction willallow the distal end 1072 to pass through the window 1062, releasing theclip 1000. In this embodiment, the proximal end 1070 of the hitch wire1068 has a thumb-loop that assists in grasping for manipulation of thehitch wire 1068, such as pushing and pulling. It may be appreciated thatthe proximal end 1070 may have a variety of shapes and features toassist in manipulation.

Referring back to FIG. 123 , the first arm 1002 a is longer and isadvanced into the first airway AW1 prior to positioning of the secondarm 1002 b. Once the first arm 1002 a enters the first airway AW1, theclip 1000 is optionally rotated to angle and align the second arm 1002 bwith the second airway AW2. This is achieved by rotating the deploymentdevice 1014. As depicted in FIG. 124 , the position of the clip 1000 isfixed in relation to the deployment device 1014 because the proximal end1008 of the clip 1000 is held within the window 1062 by the hitch wire1068. Thus, rotation of the deployment device 1014 is transmitted to theclip 1000. Once the second arm 1002 b is desirably rotated, the clip1000 is further advanced so the arms 1002 a, 1002 b are advanced furtherinto the airways AW1, AW2. Once the clip 1000 is desirably positioned(e.g. the proximal end 1008 is positioned within the ostium OS near thebifurcation), the hitch wire 1068 is retracted so as to open the window1062. Retraction of the deployment device 1014 then allows the clip 1000to slide along the top edge 1064 of the window 1062 and out of thewindow 1062. The deployment device 1014 and delivery device 1010 canthen be removed, leaving the clip 1000 behind.

Invertible Pulmonary Treatment Device Embodiments

A variety of embodiments of invertible pulmonary treatment devices 2000are provided. The devices 2000 are comprised of a shape memory materialor one or more materials that can be strained more than 2% strain beforeplastic and permanent deformation. The devices 2000 are able to beexpanded under tension, and then are able to recoil back toward anoriginal relaxed or resting shape. Thus, each device 2000 is able to bestrained, tensioned or expanded to store energy, wherein the energy isutilized to continually provide shape recovery which maintains tensionon the lung tissue as the device 2000 relaxes, self-recovers and becomesless strained as it transitions toward its original shape. In theseembodiments, a portion of the device 2000 is invertible. In someembodiments, the invertible portion inverts during expansion of thedevice 2000 and relaxes toward an uninverted orientation, tensioning thelung as it relaxes. However, it may be appreciated that in someembodiments the invertible portion relaxes toward an invertedorientation from an uninverted orientation. It may be appreciated thatin some embodiments inversion comprises partial inversion and recoveryof inversion comprises partial recovery. Thus, in some embodiments, thedevice 2000 fully inverts and partially recovers (i.e. uninverts) and insome embodiments the device 2000 partially inverts and fully recovers(i.e. univerts). In some embodiments, the invertibility, inversionability or amount of inversion of the device 2000 provides a distinctvisual indication to the user as to the changing tension in the lungtissue during placement of the device 2000 and after implantation. Insome embodiments, while the device 2000 is in its relaxed configuration(prior to inversion), slacked tissue is being gathered with minimal orno tension applied to the lung. Inversion begins once slacked tissue istaut and force is continued to be applied to the device 2000. Suchinversion can be achieved by extremely low forces allowing finegranularity of control while force is applied to the device 2000 andattached lung tissue. In some embodiments, the forces that deform theimplant into the inverted position are approximately similar to normallung tissue elastic recoil force (e.g. in a range between 0.001 poundsforce per inch to 1.0 or more pounds force per inch). Thus, theinvertible pulmonary treatment devices 2000 typically have a very lowmodulus of elasticity or spring constant. This allows the user to beable to manipulate the device 2000, particularly so as to apply tensionto the lung L, without risking tearing the lung tissue or ripping thedevice 2000 from the lung tissue. Thus, the inversion acts as a clutchto prevent sudden failure of the extremely degraded lung tissue to whichthe device 2000 has attached or grasped. Example embodiments ofinvertible pulmonary treatment devices 2000 and example methods ofdelivery are provided herein.

FIG. 127 illustrates an embodiment of an invertible pulmonary treatmentdevice 2000 emerged from a delivery device 2010, such as a catheter.FIG. 127 illustrates the device 2000 in its relaxed state, withoutinversion. For reference the device 2000 may be considered to bedisposed within a three dimensional space defined by an x-axis (axis2016), a y-axis (longitudinal axis 2012) and a z-axis (axis 2011). Thus,plane of the paper is considered to substantially correlate to the x-yplane. In this embodiment, the device 2000 includes at least oneinversion element 2002 and at least one anchoring element 2004 which aredisposed near opposite ends of the device 2000 along the longitudinalaxis 2012. In particular, in this embodiment, the device includes afirst inversion element 2002 a and a second inversion element 2002 b,each of which extend along the longitudinal axis 2012 and then curveradially outwardly away from the longitudinal axis 2012 forming a looparound an axis 2014 (i.e. the first inversion element 2002 a forms aloop around a first axis 2014 a and the second inversion element 2002 bforms a loop around a second axis 2014 b). Each of the first and secondaxis 2014 a, 2014 b are parallel to axis 2011 (z-axis) and thereforeextend substantially out of the page. Typically, the first axis 2014 ais spaced apart from the longitudinal axis 2012 and perpendicular to theplane of the loop of the first inversion element 2002 a. In thisembodiment, the first and second inversion elements 2002 a, 2002 bextend in opposite directions from the longitudinal axis. In someembodiments, the outer diameter of the loop of the first or secondinversion elements 2002 a, 2002 b is in the range of 0.400 inches to 3.0inches in diameter or any size between. Most preferably, the loop mayhave an outer diameter in the range of 0.75 inches to 1.25 inches. Inthis embodiment, each of the first and second inversion elements 2002 a,2002 b curve to form a respective holding element or tissue gatheringelement 2006 a, 2006 b which will be used to capture and hold tissueduring positioning of the device 2000. In this embodiment, each tissuegathering element 2006 a, 2006 b has a loop shape which terminates inits respective distal tip 2008 a, 2008 b. In some embodiments, the outerdiameter of the loop of the first or second tissue gathering elements2006 a, 2006 b is in the range of 0.1 inches to 0.9 inches in diameteror any size between. Most preferably, the loop may have an outerdiameter in the range of 0.2 inches to 0.3 inches. In this embodiment,each tissue gathering element 2006 a, 2006 b extends around an axis2016′ which is parallel to and above axis 2016 so as to form a loopresiding in the y-z plane. Thus, in this embodiment, the axis 2016′ isperpendicular to the longitudinal axis 2012 so that the loops of thetissue gathering elements 2006 a, 2006 b lie in parallel planes, each ofwhich are substantially perpendicular to the plane of the inversionelements 2002 a, 2002 b. Likewise, in this embodiment, the axis 2016′ isoffset from the longitudinal axis 2012 so that the tissue gatheringelements 2006 a, 2000 b protrude upwardly (out of the page). In thisembodiment, the tissue gathering elements 2006 a, 2006 b are disposednear the inversion elements 2002 a, 2002 b, such as aligned with theinversion elements 2002 a, 2002 b. For example, in this embodiment, ifthe loops of the tissue gathering elements 2008 a, 2008 b were bent downinto the plane of the inversion elements 2002 a, 2002 b, the tissuegathering elements 2008 a, 2008 b would reside within the loops of theinversion elements 2002 a, 2002 b. It may be appreciated that the tissuegathering elements 2006 a, 2006 b may have a variety of shapes and maybe positioned in a variety of orientations in relation to the inversionelements 2002 a, 2002 b.

In this embodiment, the invertible pulmonary treatment device 2000includes an anchoring element 2004 positioned opposite the inversionelements 2002 a, 2002 b (i.e. spaced apart from the inversion elements2002 a, 2002 b along the longitudinal axis 2012. In this embodiment, theanchoring element 2004 has a coiled shape, wherein each turn of the coilextends at least partially around the longitudinal axis 2012. Theanchoring element 2004 is configured to be positioned within a lungpassageway, such as an airway or ostium OS.

FIG. 128 illustrates an embodiment of an invertible pulmonary treatmentdevice 2000 that is similar to that illustrated in FIG. 127 . Here, thedevice 2000 is released from the delivery device so as to reveal theremainder of its proximal end. In this embodiment, the anchoring element2004 comprises three turns of a coil and then dips down to form anattachment feature 2020. In this embodiment, the attachment feature 2020has the form of a small loop that can be grasped, tethered or otherwisecoupled to a portion of a delivery device 2010.

FIG. 129 illustrates another embodiment of an invertible pulmonarytreatment device 2000. Here, the device 2000 is emerging from a deliverydevice 2010 and has inversion elements 2002 a, 2002 b and tissuegathering elements 2006 a, 2006 b similar to those of FIGS. 127-128 . Inthis embodiment, the device 2000 has an anchoring element 2004comprising a plurality of loops around the longitudinal axis 2012. Here,the anchoring element 2004 is formed from two portions of a shaft whichextend around in a first loop shape and then cross to form an additionalloop shape substantially concentric with the first loop shape below.

FIG. 130 illustrates another embodiment of an invertible pulmonarytreatment device 2000. Here, the device 2000 is released from thedelivery device so as to reveal the remainder of its proximal end. Inthis embodiment, the anchoring element 2004 comprises an arc shapeextending at least partially around the longitudinal axis 2012. In thisembodiment, the attachment feature 2020 has the form of a small loopthat can be grasped, tethered or otherwise coupled to a portion of adelivery device 2010.

It may be appreciated that the invertible pulmonary treatment device2000 may be formed from a single continuous shaft or from a combinationof two or more elements acting as a continuous shaft that are fixedtogether, such as by welding, gluing, thermally friction bonding,crimping, locking together using puzzle lock patterns, locking extrusionsections within each other, wrapping with a spring, riveting, lockingtogether with threaded fasteners, or by joining using locking hardwarethat is known in the art. The devices 2000 illustrated in FIGS. 127-130are comprised from a single continuous shaft. Such single elementdesigns enjoy the benefit of not comprising joints or links that mayfail due to strain or bending during the high number of breathing cyclesthe device may encounter during the remainder of the patient's life. Thesingle element may be made with varying diameter sections or it can bemade from tapered diameter material as well as material that has totallynon-uniform size or cross section along its length. In some embodiments,the shaft is comprised of wire, such as metal (e.g. nitinol, austeniteor martensite nitinol, spring steel, stainless steel, cobalt steelalloys, titanium etc.) or polymeric compounds, ceramic, carbon fiberand/or other biocompatible materials. Such wire is typically extruded,drawn or sintered into near net shapes or wire form. A single componentstructure may be configured with tuned material properties in differentlocations of the single element. Nitinol material may be adjusted byusing local heat treatment techniques to increase or decrease thestiffness or modulus of elasticity in local portions of the wire.

In some embodiments, the shaft has a flattened, ribbon shape. In someembodiments, the ribbon shape is between 0.005 and 0.030 inches wide andbetween 0.005 and 0.030 inches thick in dimension. The ribbon may beblasted or tumbled in abrasive media to round the edges so it moreclosely appears like a round cross-section wire. Alternatively, theshaft may be made from round cross section wire, for example having adiameter between 0.003 and 0.050 inches. In some embodiments, theanchoring element 2004 may be configured to form a coil shaped stent orhelix with an outer diameter of the helix that is between 5 mm and 17 mmin diameter but more preferably it is between 6 mm and 10 mm indiameter.

One or more invertible pulmonary treatment devices 2000 may bepositioned within the lungs L as will be described herein. It may beappreciated that a plurality of invertible pulmonary treatment devices2000 may be positionined within a single airway, within multipleairways, within a single lung or within both lungs. Likewise, in someinstances, the invertible pulmonary treatment devices 2000 may be usedin combination with other pulmonary treatment devices described hereinor in combination with conventional implantable therapeutic devices andtreatment techniques.

FIG. 131 illustrates a branched lung passageway comprising a firstairway AW1 that extends into damaged tissue DT in the area of alveoli.In such areas of damaged tissue DT, large portions of parenchyma areoften unsupported, loose or missing, forming coalesced blebs and bullae.Thus, any existing tissue is sponge-like and very weak. FIG. 131 alsoillustrates airways A that have collapsed near the area of damagedtissue DT. In this embodiment, a bronchoscope 20 is advanced into thelung passageway and a delivery device 2010 is advanced through thebronchoscope 20 so that the distal end 2013 of the delivery device 2010resides within the first airway AW1. In this embodiment, the invertiblepulmonary treatment device 2000 is disposed within the distal end 2013.Therefore, the distal end 2013 is positioned at the target locationwithin the first airway AW1 for deployment of the device 2000 therefrom.It may be appreciated that in some embodiments the target location iswithin damaged tissue DT or other tissue where airway walls are notpresent.

FIG. 132 illustrates an early step in this embodiment of the process ofdeployment of the device 2000. Here, the device 2000 is advanced withinthe delivery device 2010 (or the delivery device 2010 is retracted) sothat the distal tips 2008 a, 2008 b emerge from the distal end 2013 ofthe delivery device 2010. Due to the precurvature of the tissuegathering elements 2006 a. 2006 b, the tips 2008 a, 2008 b begin tocurve radially outwardly in opposite directions. In this step of thisembodiment, the first distal tip 2008 a penetrates the wall W of thefirst airway AW1 and extends into the damaged tissue DT. The seconddistal tip 2008 a does not penetrate the wall W and begins to curvewithin the first airway AW1. It may be appreciated that these serve asexamples and the tips 2008 a, 2008 b may act the same or differently,penetrating the wall W or not, advancing into the damaged tissue or not.In any situation, tissue (either wall tissue, damaged tissue or othertissue) is grasped, even if such grasping is by frictional force ordenting into the wall to form a purchase area. Additional portions ofthe tissue gathering elements 2006 a, 2006 b are exposed to allow theinversion elements 2002 a, 2002 b to emerge. In some embodiments, as theinversion elements 2006 a, 2006 b form, the grasped tissue is moreadequately held and/or additional tissue is grasped.

FIG. 133 illustrates an example of the inversion elements 2002 a, 2002 bfully deployed. Since the tissue gathering elements 2006 a, 2006 b aregrasping and holding tissue, the remainder of the inversion elements2002 a, 2002 b loop up and over the tissue gathering elements 2006 a,2006 b. FIG. 133 illustrates the inversion elements 2002 a, 2002 bextending into the damaged tissue DT and the tissue gathering elements2006 a, 2006 b grasping damaged tissue DT.

At this point in this embodiment of the deployment procedure, the device2000 is partially deployed and able to start applying tension orsignificantly increase tension applied to the lung tissue. The portionof the device 2000 coupled to the catheter 2010 is then pulled in theproximal direction, either by applying pulling force to the proximalportion of the device 2000, applying pulling force to the catheter 2010and/or applying pulling force to the bronchoscope 20. Since the tissuegathering elements 2006 a, 2006 b have grasped tissue, typically damagedtissue DT, the damaged tissue DT is pulled in the proximal direction aswell. This continues until the tissue slack is gathered. At some point,the slacked tissue will become sufficiently gathered and tension willbegin to develop in the lung tissue. It is at this point that the useris to be particularly diligent so as to not tear the tissue with excesspulling force. This is assisted by the invertible design of the device2000. Once the lung tissue is sufficiently taut, additional pullingforce serves to invert the device 2000. FIG. 134 illustrates a device2000 that has been pulled so that the inversion elements 2002 a, 2002 bhave inverted. Thus, the portions of the inversion elements 2002 a, 2002b that were previously disposed above the tissue gathering elements 2006a, 2006 b are now disposed below the tissue gathering elements 2006 a,2006 b. As shown, the airways A that were previously collapsed are nowopen, becoming rounder and larger. The airways A are also shifted moreproximally; in some instances, this tissue can be relocated quitesubstantially. FIG. 134 illustrates the nearby tissue being tensioned(straightened lines) and the damaged tissue DT is compressed (curvedlines representing loose, floppy tissue) by the device 2000. The obviousdeformation of the device 2000 gives the user a distinct visualindication as to how far to pull the system back. If the lung tissue isextremely slacked, the device 2000 may be shifted proximally 1 mm to 100mm, in some instances, before tension is restored. Only afterrestoration of tension will the device 2000 begin to elongate andinvert. By incorporating a curvilinear design with loops or other shapesthat are non-straight, the deformation of the device 2000 may beaccomplished with extremely low forces. In some instances, the forcesused to deform the implant are approximately similar to normal lungtissue elastic recoil force, such as in a range between 0.001 poundsforce per inch to 1.0 or more pounds force per inch. By providing avisual signal (implant deformation) that more than zero net tension hasbeen generated in the tissue and by providing a deformable implantabledevice 2000 with a very low modulus of elasticity or spring constant,the user can pull the proximal end of the device 2000 without riskingtearing the lung tissue and/or ripping the device 2000 from the tissue.Thus, the low force deformable device 2000 can act as a clutch toprevent suddenly ripping the inversion elements 2002 a, 2002 b out ofeven extremely degraded lung tissue.

The inverted arrangement of the device 2000 also stores potential energyor spring force to enhance lung elastic recoil. The inversion andextension of the inversion elements 2002 a, 2002 b stores potentialenergy to maximize duration of effect to provide chronic force to thelung to take up slack as the diseased tissue elongates over time.

The device 2000 is then anchored in place. This is achieved by deployingthe anchoring element 2004. FIG. 135 illustrates an embodiment of theanchoring element 2004 deployed by retraction of the delivery device2010 and optionally the bronchoscope 20. Here, the anchoring element2004 bows outwardly within the first airway AW1 and anchors against theairway walls W. It may be appreciated that the anchoring element 2004may anchor against the wall W by frictional force, creating an indent inthe wall W and a tissue ledge which impedes movement or by penetratingthe wall W. It may also be appreciated that the anchoring element 2004may alternatively be deployed within the ostium OS.

FIG. 136 illustrates the device 2000 decoupled from the delivery device2010, revealing the attachment feature 2020. Such decoupling allows thedevice 2000 to elastically recover to a shorter length. Thus, theinversion elements 2002 a, 2002 b and the anchoring element 2004 aredrawn toward each other. In some instances, this includes partial ortotal reverse of the inversion, as illustrated in FIG. 136 . The tissuedistal to, proximal to and adjacent to the device 2000, and in someinstances generally everywhere in the lung, is tensioned more and thelung elastic recoil is restored. The tissue immediately between theinversion elements 2002 a, 2002 b and the anchoring element 2004 iscompressed and that relative volume is reduced (lung volume reduction)as shown by the squiggly lines representing compressed tissue. Thecross-sections of the airways A are now large and round as the tensionedtissue provides radial outward suspension to hold them open. Thedelivery device 2010 and bronchoscope 20 are then removed and the device2000 is left behind as an implant.

FIG. 137A illustrates another embodiment of an invertible pulmonarytreatment device 2000. Here, the device 2000 is shown in its relaxedstate, without inversion. In some embodiments, the overall length of thedevice 2000 in the relaxed state is from 5-250 mm, preferably 75-110 mmfor short airways and 100-150 mm for long airways that are found in thelower lobes of the lung. The shortening ratio can be 2:1 up to 100:1 buttypically 10:1 (distance between the tissue gathering elements 2006 a,2006 b and the proximal anchoring element 2004 starts out 100 mm andends up 10 mm).

In this view, the tissue gathering elements 2006 a, 2006 b are disposedbelow the inversion elements 2002 a, 2002 b. The inversion elements 2002a, 2002 b reside in an x-y plane, defined by an x-axis (axis 2016) and ay-axis (longitudinal axis 2012). The first inversion element 2002 a andthe second inversion element 2002 b both extend along the longitudinalaxis 2012 and then curve radially outwardly away from the longitudinalaxis 2012 forming a loop around an axis 2011 (z-axis). In someembodiments such a loop has a diameter of 0.2-3 inches, such as 0.4-1inches. In this embodiment, the inversion elements 2002 a, 2002 b areshown both curving to the right of the longitudinal axis 2012, but itmay be appreciated that both may curve to the left of the longitudinalaxis 2012. In both cases, the inversion elements 2002 a, 2002 b areconcentric with each other. It may be appreciated that in someembodiments each of the inversion elements 2002 a, 2002 b extend alongthe longitudinal axis 2012 and then curve radially outwardly away fromthe longitudinal axis 2012 and each other, each forming a loop around aseparate axis (2011 a, 2011 b), as illustrated in FIG. 137B. However, inthe examples shown herein below, the inversion elements 2002 a, 2002 bare described and illustrated as being concentric to create a morecompact device design.

FIG. 138 provides a side view of the device 2000 of FIG. 137A. Thisshows that the tissue gathering elements 2006 a, 2006 b are disposedbelow the inversion elements 2002 a, 2002 b, extending downward in thenegative direction of the axis 2011 (z-axis) and looping around an axis2017 which is parallel to axis 2016 (x-axis) and perpendicular to boththe longitudinal axis 2012 and the axis 2011 (z-axis). Thus, axis 2017is parallel to the x-y plane. In some embodiments, the tissue gatheringelements 2006 a, 2006 b loop around an axis 2017 forming a circle havinga diameter of 1-18 mm, such as 6-8 mm. It may be appreciated that anysuitable number of tissue gathering elements 2006 a, 2006 b may beformed by additionally looping around the axis 2017, such as 1-20 times,however 2-3 is preferred. Thus, the inversion elements 2002 a, 2002 band the tissue gathering elements 2006 a, 2006 b reside in perpendicularplanes and are adjacent to each other. This allows the elements 2002 a,2002 b, 2006 a, 2006 b to recoil closely together (i.e. in closeproximity) so as to minimize the space that they occupy in the lung whenin the device 2000 is in the relaxed position.

In this embodiment, the device 2000 includes at least one anchoringelement 2004. In this embodiment, the anchoring element 2004 loops overitself to create a circular portion that extends around an axis 2019parallel to the longitudinal axis 2012. Typically, the axis 2019 isabove the longitudinal axis 2012. Thus, the anchoring element 2004extends upward in the positive direction of the z-axis. This allows theaxis 2019 to be concentric with a central axis of an airway lumen whilethe inversion elements 2002 a, 2002 b and tissue gathering elements 2006a, 2006 b are off to the side, leaving the airway lumen patent.

The devices 2000 illustrated in FIGS. 137A, 137B, 138 may be comprisedfrom a single continuous shaft or from a combination of two or moreelements acting as a continuous shaft. Single element designs enjoy thebenefit of not comprising joints or links that may fail due to strain orbending during the high number of breathing cycles the device mayencounter during the remainder of the patient's life. The single elementmay be made with varying diameter sections or it can be made fromtapered diameter material as well as material that has totallynon-uniform size or cross section along its length. In some embodiments,the shaft is comprised of wire, such as metal (e.g. nitinol, austeniteor martensite nitinol, spring steel, stainless steel, cobalt steelalloys, titanium etc.) or polymeric compounds, ceramic, carbon fiberand/or other biocompatible materials. Such wire is typically extruded,drawn or sintered into near net shapes or wire form. A single componentstructure may be configured with tuned material properties in differentlocations of the single element. Nitinol material may be adjusted byusing local heat treatment techniques to increase or decrease thestiffness or modulus of elasticity in local portions of the wire.

In some embodiments, the shaft has a flattened, ribbon shape. In someembodiments, the ribbon shape is between 0.005 and 0.030 inches wide andbetween 0.005 and 0.030 inches thick in dimension. The ribbon may beblasted or tumbled in abrasive media to round the edges so it moreclosely appears like a round cross-section wire. Alternatively, theshaft may be made from round cross section wire, for example having adiameter of 0.01-5 mm, preferably 0.25-0.5 mm. In some embodiments, thiscreates a bearing area of 0.05-3000 mm². In some embodiments, the shafthas a highly reflective finish to enhance endothelium attachment, so asto reduce the time to grow over with a biocompatible layer of tissue toreduce granular tissue formation.

FIGS. 139A-139D illustrate an embodiment of a delivery system 2100 of aninvertible pulmonary treatment device 2000. In this embodiment, thedelivery system 2100 comprises a guidewire 2102, a catheter 2104, anintroducer 2106 and a bronchoscope 20. FIG. 139A illustrates anembodiment of a guidewire 2102. The guidewire 2102 may be comprised ofany suitable material to provide flexibility, strength and pushability.In some embodiments, the guidewire 2102 is comprised of wire ropestainless steel or titanium, such as having 1-2000 strands, moreparticularly 400 strands. This provides high flexibility whileeliminating gaps in the wire rope during bending. In such embodiments,the strands are continuous from distal tip to proximal end, wherein thedistal tip is welded. In some embodiments, the guidewire 2102 has across-sectional diameter of 0.05-5 mm, particularly 1.5 mm. In someembodiments, the guidewire 2102 includes a series of markers 2110, suchas marker bands which extend around the circumference of the guidewire2102. In this embodiment, the markers 2110 are spaced 0.1-3 inches apart(measured from the start of one marker 2110 to the start of the nextmarker 2110), preferably 0.45 inches mm apart. Typically, the markers2110 extend along the length of the guidewire 2102, however it may beappreciated that the markers 2110 may be disposed only along theproximal end, only along the distal end or along any or all portions ofthe guidewire 2102. In some embodiments, visualization of the markers2110 along the proximal end will allow the user to determine theposition of the distal end relative to other components of the deliverysystem 2100, particularly the catheter 2104 through which it passes. Or,the position of the guidewire 2102 may be determined relative to theintroducer 2106 as the introducer 2106 may be connected to and extendingthe effective length of the catheter 2104. In some embodiments, themarkers 2110 are comprised of fluorescent paint so the markers 2110 arevisible in a low light room (outside of the body) or under fluoroscopy(within the body). In other embodiments, the markers 2110 are comprisedof white polymer that has fluorescent properties. In yet otherembodiments, the markers 2110 are comprised of black laser markingswhich are generated from laser annealing the stainless steel wire to ablack condition using a fiber laser. In some embodiments, the laser hasa 1064 nm wavelength producing 1-100 watts and producing a long pulsewidth at 1-500 kHz frequency, such as a 2 kHz frequency. In someembodiments, the distal tip 2112 of the guidewire 2102 is plasma or TIGwelded into a ball having diameter of 0.01-5, preferably 1.5 mm. In someembodiments, the proximal end of the guidewire 2102 has a hub, such as apolycarbonate hub.

FIG. 139B illustrates an embodiment of a catheter 2104. In someembodiments, the catheter 2104 comprises a shaft 2150 having a proximalend 2152 and a distal end 2154. The shaft 2150 is sized and configuredto be advanced through a working lumen of a bronchoscope 20,particularly a bronchoscope having an inner diameter of 1.8-3.6 mm.Likewise, the shaft 2150 has an internal lumen sized and configured forpassage of the guidewire 2102 therethrough. In some embodiments, theshaft 2150 is comprised of polyether block amide, such as known underthe tradename of PEBAX® (Arkema). This allows the shaft 2150 to beelectron beam or gamma sterilized. This is preferable to ethylene oxidesterilization which has environmental hazards. Conventional cathetersoften have polytetrafluoroethylene liners which require ethylene oxidesterilization. Therefore, in preferred embodiments the shaft 2150 isfree of polytetrafluoroethylene. In some embodiments, Shore D 50-100durometer, preferably 70 durometer, liner of polyether block amide orpolyether ether ketone is utilized. In some embodiments, a lowerdurometer outer jacket is used. This allows the shaft 2150 to bendwithout kinking. In other embodiments, a stainless steel braided frameis provided as a jacket. In this embodiment, the catheter 2104 includesa proximal fitting 2156 which mates with a distal fitting 2158 disposedalong the distal end of the introducer 2106. In this embodiment, theproximal fitting 2156 comprises a male luer fitting.

FIG. 139C illustrates an embodiment of an introducer 2106. Theintroducer 2106 is utilized to house the invertible pulmonary treatmentdevice 2000 prior to and during delivery. Thus, the introducer 2106 ispreloaded with the device 2000 so that the device is properly loaded andready for delivery. In this embodiment, the introducer comprises a tube2200 having a proximal end 2210 and a distal end 2220, wherein theinvertible pulmonary treatment device 2000 is preloaded within the tube2200 and disposed near the distal end 2220. In some embodiments, thetube 2200 is comprised of perfluoroalkoxy alkane (PFA). In thisembodiment, the distal fitting 2158 comprises a female luer fitting soas to mate with the male luer fitting of the catheter 2104 in FIG. 139B.This allows the distal end 2220 of the introducer 2106 to connect withthe proximal end of the catheter 2150. Ultimately, the device 2000 willbe advanced from the introducer 2106 through the catheter 2150, as willbe described in detail herein.

The introducer 2106 includes a plunger 2222 having an elongate member2224 that extends into the proximal end 2210 of the tube 2200. Theelongate member 2224 has a coupling element 2226 at its distal end. Thecoupling element 2226 is configured to couple with the invertiblepulmonary treatment device 2000. In some embodiments, the elongatemember 2224 is comprised of turned rope stainless steel cable. In someembodiments, the elongate member 2224 has a cross-sectional diameter of0.05-5 mm, such as 0.75-1.25 mm. In some embodiments, the elongatemember 2224 is 10-60 inches in length, such as 40-50 inches in length.

In this embodiment, the coupling element 2226 has a hook-shape whereinthe attachment feature 2020 of the device 2000 slides over the hook ofthe hook-shape and rests in a cut-out. In some embodiments, the couplingelement 2226 is comprised of stainless steel, titanium, plastic,ceramic, metal, etc. and is crimped on or glued with epoxy to theelongate member 2224. It may be appreciated that in other embodimentsthe coupling element 2226 is welded to the elongate member 2224. In someembodiments, the coupling element 2226 is 1-30 mm, such as 5 mm, inlength. This allows the rigid coupling element 2226 to be short enoughto pass through bends of the insertion cord tip 208 of the bronchoscope20. In some embodiments, the cut-out has a cut depth of 0.01 to 3 mm,such as 0.5 mm. And, in some embodiments, coupling element 2226 has athickness of 0.1-2 mm, such as 0.25 mm, in the area of the cut-out toallow the wire of the attachment feature 2020 of the device 2000 to sliparound it and reside in the cut-out.

In some embodiments, the plunger 2222 includes a sheath 2228 whichextends over the elongate member 2224 and retains the attachment feature2020 of the device 2000 in the cut-out of the hook-shaped element. Thiskeeps the device 2000 coupled to the plunger 2222. In some embodiments,the sheath 2228 is comprised of polyether ether ketone (PEEK). In someembodiments, the space within the introducer 2106, between the couplingelement 2226 and the distal fitting 2158, is 20-500 mm, preferably150-170 mm. This area within the introducer 2106 houses the pre-loadeddevice 2000 in its extended (tensioned) configuration.

The introducer 2106 further includes a handle 2230 at its proximal end.The handle 2230 is configured to actuate the coupling element 2226 so asto decouple the device 2000. In particular, the handle 2230 includes apush button 2232 that is coupled to the plunger 2222 so that depressionof the push button 2232 advances the plunger 2222 so that the couplingelement 2226 advances from the sheath 2228, revealing the hook-shapedelement with cut-out. This allows the attachment feature 2020 to releasefrom the cut-out, thereby releasing the device 2000 from the deliverysystem. Typically, the length of the push button 2232 is proportional tothe distance that the plunger 2222 moves. In some embodiments, the pushbutton 2232 extends 1-20 mm, such as 10 mm, from the handle 2230. Insome embodiments, considerable force is used to push the push button2232, such as 1-20 pounds of force, particularly 6 pounds of force, soas to avoid accidental release of the device 2000. In some embodiments,this is achieved with spring-loading. In some embodiments, the pushbutton 2232 is able to be depressed so that the button 2232 is flushwith the handle 2230 and is retained in this position. This ensures thatthe push button 2232 cannot be pulled back again and the introducer 2106cannot be reused by the user. Such reuse may lead to inappropriateloading of the introducer 2106 with the device 2000.

FIG. 139D illustrates the insertion cord tip 208 of a bronchoscope 20.The bronchoscope 20 includes a light source which may be halogen,incandescent or LED, to name a few. As shown, the working channel 210extends through the tip 208, allowing delivery of the guidewire 2102,catheter 2104 and introducer 2106 therethrough.

The delivery system 2100 is utilized to deliver the invertible pulmonarytreatment device 2000 to the lung anatomy, particularly to an area ofdamaged tissue DT. The invertible pulmonary treatment devices 2000described herein may be placed in any lung, lobe, mainstem bronchi,lobar bronchi, segmental bronchi, sub-segment bronchi or even fartherdown the airway tree. Typically, the device 2000 is advanced beyond a4^(th) generation airway (e.g. 5^(th) generation, 6^(th) generation,7^(th) generation, etc) into damaged tissue and anchored in a 4^(th)generation airway or lower generation airway. Although the methods anddelivery devices described herein are endoscopic, it may be appreciatedthat many embodiments of the devices 2000 may be placed directly throughthe chest wall into the lung or through the wall of the main bronchi toaccess pockets of destroyed parenchyma. Many of the devices may beimplanted via open chest procedure or with the use of any type ofendoscope.

For endoscopic delivery, the insertion cord tip 208 of the bronchoscope20 is typically advanced through the trachea T, a main stem bronchi,into a lobar airway and into a segmental airway. The guidewire 2102 andcatheter 2106 are then removed from the packaging and inserted into theworking channel 210 of the bronchoscope so that the guidewire 2102passes through the catheter 2106. FIG. 140 illustrates the insertioncord tip 208 of the bronchoscope 20 inserted into a lung passageway. Thedistal end of the catheter 2104 extends a short distance from thebronchoscope 20 and the guidewire 2102 extends into the lung anatomy.Three locations are demarcated within the lung anatomy by dashed linesin FIG. 140 : (A) the desired location of the anchoring element 2004 ofthe device 2000, (B) the initial desired location of the tissuegathering elements 2006 a, 2006 b of the device 2000, and (C) thelocation of the pleura or damaged tissue, such as bleb pockets or bullaepockets of damage. Location A is within a lung passageway having intactwalls so as to allow anchoring therein. Location B is within damagedtissue, such as unsupported tissue, alveoli, loose tissue, tissue havingbleb pockets or bullae, or may be within a lung passageway.

In some embodiments, the guidewire 2102 is advanced until its distal tip2112 reaches the pleura (location C). The construction of the guidewire2102 causes the guidewire 2018 to be advanced in a straightconfiguration (e.g. like a fishing pole) until it makes contact withtissue wherein it become flexible. Thus, when the guidewire 2102 reachesthe pleura it curls into the pockets and cannot be advanced further. Ifthe distal tip 2112 enters damaged tissue (e.g. appears as “swiss cheeseholes”) the distal tip will curl. In some embodiments, the distal tip2112 of the guidewire 2102 extends 20-300 mm, typically 130-180 mm, fromthe distal end of the catheter 2104 (e.g. from location A to locationC). The guidewire 2112 is then pulled back, such as 30-50 mm, so thatthe distal tip 2112 of the guidewire 2102 is at location B, asillustrated in FIG. 140 . This provides a buffer distance between theinitial desired location of the tissue gathering elements 2006 a, 2006 bof the device 2000 (i.e. furthest reach of the device 2000) and thepleura.

The distance between location A and location B is measured with the useof the markers 2110. As mentioned previously, the markers 2110 extendalong the length of the guidewire 2102 or are disposed along the distalend and/or along the proximal end of the guidewire 2102 in a manner sothat visualization of the markers along the proximal end will allow theuser to determine the length of the distal end of the guidewire 2102that is exposed. Alternatively or in addition, the distal markers 2110may be visualized with the use of visualization techniques, such asfluoroscopy. Therefore, the distance between location A and location Bcan be calculated. This distance is utilized to determine the size ofthe device 2000 to be implanted. The more markers 2110 between locationA and location B, the longer the device 2000 and the fewer markersbetween location A and location B, the shorter the device 2000. Theintroducer 2106 having the desired length pre-loaded device 2000 is thenobtained.

The catheter 2106 is then advanced further into the working channel 210of the bronchoscope 20 so that the distal end 2154 of the catheter 2104is located at location B, as illustrated in FIG. 141 . At this point thecatheter 2106 is properly positioned for delivery of the device 2000.The introducer 2106 housing the desired device 2000 is then coupled tothe proximal end of the catheter 2104 for delivery therethrough.

FIG. 142 illustrates the catheter 2104 inserted into the working channel210 of the bronchoscope 20 so that its proximal end emerges from theworking channel 210. As shown, the proximal fitting 2156 of the catheter2104 is mated with the distal fitting 2158 of the introducer 2106. Thisallows the device 200 to be pushed through the introducer 2106 and intothe catheter 2104. This is achieved by advancing the plunger 2222 sothat the elongate member 2224 moves through the tube 2200 and into thecatheter 2104. As the plunger 2222 is advanced, the elongate member 2224pushes the device 2000 through the catheter 2104. This continues untilthe device 2000 reaches the distal end of the catheter 2104.

FIG. 143 illustrates the device 2000 reaching the distal end 2154 of thecatheter 2104. Here, the distal end 2154 of the catheter 2104 is shownpositioned within the damaged tissue DT at location B of FIG. 141 . Thedevice 2000 is collapsed in an extended (tensioned) position so that thedistal tips 2008 a, 2008 b facing distally, poised to be the firstportion of the device 2000 to be deployed from the catheter 2104. Insome embodiments, the distal tips 2008 a, 2008 b are spaced apart by0.5-10 mm, such as 1 mm, when the device 2000 is in the collapsedconfiguration. In some embodiments, such spacing is achieved by havinginversion elements 2002 a, 2002 b and/or tissue gathering elements 2006a, 2006 b that are of different lengths. This allows the catheter 2104to have a small lumen size, such as an inner diameter of 5 mm,preferably 2 mm. This also allows the distal tips 2008 a, 2008 b toavoid entanglement or collision with each other during deployment. Itmay be appreciated that the distal tips 2008 a, 2008 b may have anysuitable shape, including loops, ground ribbon, coils, strain reliefs orballs. In some embodiments, the distal tips 2008 a, 2008 b have adiameter of 0.25-2 mm, preferably 0.75 mm.

Deployment begins when the device 2000 is incrementally exposed at thedistal end of the catheter 2104. In some embodiments, the catheter 2104is retracted, as indicated by the arrow 2300. In other embodiments, thedevice 2000 is advanced such as by pushing with the plunger 2222. Thespeed in which the device 2000 is deployed is controlled by the speed inwhich the device 2000 is exposed, such as the speed in which thecatheter 2014 is retracted. Thus, in some embodiments, deployment isachieved slowly and methodically. It may be appreciated that the device2000 remains fixed to the coupling element 2226 of the plunger 2222until the push button 2232 is depressed. Simply advancing or retractingthe plunger 2222 or the catheter 2104 will not release the device 2000from the plunger 2222.

FIG. 144 illustrates the device 2000 as it is emerged further from thecatheter 2104. Here, the tissue gathering elements 2006 a, 2006 b areshown emerging from the distal end 2154 of the catheter 2104, splayingout in opposite directions from the longitudinal axis 2012 as indicatedby arrows 2302. In some embodiments, the tissue gathering elements 2006a, 2006 b have sufficient bearing area against the damaged tissue DT sothat they do not “cheese wire” or cut through the damaged tissue DT.This allows the tissue gathering elements 2006 a, 2006 b to wind intothe damaged tissue DT without cutting sideways through the tissue DT.Thus, the damaged tissue DT will be able to be wrapped up by the tissuegathering elements 2006 a, 200 b. In some embodiments, the ball-shapeddistal tips 2008 a, 2008 b are large enough to keep from hanging up inthe damaged tissue DT but small enough to push through lung tissue whilewinding into the tissue.

FIG. 145 illustrates further advancement of the tissue gatheringelements 2006 a, 2006 b into the damaged tissue DT. As the tissuegathering elements 2006 a, 2006 b advance further, their pre-curvaturebends distal tips 2008 a, 2008 b toward the proximal direction, asindicated by arrows 2304. In this embodiment, the radius curvature ofthe tissue gathering elements 2006 a, 2006 b is somewhat small, forexample the distance d between the distal tip 2008 a and thelongitudinal axis 2012 of the device 2000 is 6-8 mm. However, it may beappreciated that in other embodiments, the distance d is 1-30 mm.Likewise, in this embodiment, a distance d1 (i.e. between the distaledge of the catheter 2104 and the peak of the curving tissue gatheringelement 2006 a) is 2-5 mm, however it may be appreciated that in otherembodiments the distance d1 is 0.05-10 mm. It may be appreciated thatthese measurements and characteristics also apply to tissue gatheringelement 2006 b. Having somewhat tight curvatures (i.e. short forwarddeployment) avoids penetration of the lung wall when working in thefarther reaches of the lung anatomy.

FIG. 146 illustrates still further advancement of the tissue gatheringelements 2006 a, 2006 b into the damaged tissue DT. As the tissuegathering elements 2006 a, 2006 b advance further, their pre-curvaturebends distal tips 2008 a, 2008 b back around toward the distaldirection, as indicated by arrows 2306. Thus, the tissue gatheringelements 2006 a, 2006 b have a “rams horn” shape. This helical shapecorkscrews into the tissue upon deployment so as to grasp the lungtissue. It may be appreciated that a variety of shapes that wind intothe lung tissue upon deployment may be used so as to grasp the lungtissue. At this point the tissue gathering elements 2006 a, 2006 b arenearly fully deployed allowing the arms of the tissue gathering elements2006 a, 2006 b to curve around an axis 2016. In some embodiments, thearms of the tissue gathering elements 2006 a, 2006 b curve 180 degrees,270 degrees, 360 degrees, 450 degrees, 540 degrees or more around theaxis 2016. In some embodiments, the arms of the tissue gatheringelements 2006 a, 2006 b make 1-20 full revolutions around the axis 2016,however in most embodiments the tissue gathering elements 2006 a, 2006 bmake 0.75 to 1.5 revolutions around the axis 2016. In this embodiment,the radius of curvature of the tissue gathering elements 2006 a, 2006 bcreates a diameter of the revolutions (distance d2) of 1-18 mm, such as6-8 mm. In some embodiments, the distal tips 2008 a, 2008 b are 2-100mm, such as 5-10 mm, apart as indicated by distance d3 in FIG. 146 .Such curving of the “rams horn” shape weaves the tissue gatheringelements 2006 a, 2006 b into the damaged tissues DT so as to create areinforced grasp or grip on the loose damaged tissue DT. This grip willallow the damaged tissue T to be pulled in the proximal direction,tightening the tissue.

FIG. 147 illustrates still further advancement of the tissue gatheringelements 2006 a, 2006 b into the damaged tissue DT. At this point theinversion elements 2002 a, 2002 b begin emerging from the distal end ofthe catheter 2104. The pre-curvature of the inversion elements 2002 a,2002 b cause the tissue gathering elements 2006 a, 2006 b to move out ofposition, pulling the gripped damaged tissue DT along with them. This isthe beginning of the inversion process. In particular, the inversionelements 2002 a, 2002 b curve around axis 2014 as indicated by arrow2308, pushing the tissue gathering elements 2006 a, 2006 b up and aroundaxis 2011 toward the proximal direction. In some embodiments, theinversion elements 2002 a, 2002 b curve at least partially around acircle having a diameter indicated by distance d4 in FIG. 147 . In someembodiments, the distance d4 is 5-50 mm, such as 10-15 mm. It may beappreciated that rotating the tissue gathering elements 2006 a, 2006 bin the proximal direction (i.e. short forward deployment) avoidspenetration of the lung wall when working in the farther reaches of thelung anatomy.

FIG. 148 illustrates the catheter 2106 and plunger 2222 having beenpulled together in the proximal direction. This pulled the proximalportion of the device 2000, such as the anchoring element 2004, in theproximal direction while at least the tissue gathering elements 2006 a,2006 b remained gripping the damaged tissue DT. The device 2000 isinverted so that the tissue gathering elements 2006 a, 2006 b are nowlocated most distally and the inversion elements 2002 a, 2002 b arelocated between the tissue gathering elements 2006 a, 2006 b and theanchoring element 2004. Thus, the inversion elements 2002 a, 2002 b actas an elastic midsection. Under fluoroscopic visualization, the device2000 can be pulled until the curved inversion elements 2002 a, 2002 bstart to straighten. This indicates the slack in the damaged lung tissuehas been fully removed, and local slack and net tension is starting tobe generated. The strength of the inversion element 2002 a, 2002 b coilsare so weak that the user is able to see that a tensioning effect isbeing created long before the tissue gathering elements 2006 a, 2006 bare pulled out of the tissue. This gives the user a lot of warning andsafety margin so as to avoid contributing to damaging the lung tissuemore than the disease itself. The loops of the tissue gathering elements2006 a, 2006 b can be 0.1-5 times the loop diameter of the inversionelements 2002 a, 2002 b. However, it is preferred that the tissuegathering elements 2006 a, 2006 b are 0.4-0.75 times the inversionelements 2002 a, 2002 b in size, to keep them smaller so they arestronger than the inversion elements 2002 a, 2002 b and they stayanchored while the inversion elements 2002 a, 2002 b are extended.

Referring back to FIG. 148 , the damaged tissue DT attached to thetissue gathering elements 2006 a, 2006 b, and optionally the inversionelements 2002 a, 2002 b, was pulled in the proximal direction,stretching and tensioning the tissue between the gripped tissue and thelung wall. This is typically continued until the slack in the diseasedtissue DT is tensioned which causes overall tensioning of the lung.Deployment of the anchoring element 2004 allows the anchoring element2004 to bend into its pre-curvatured shape, thereby anchoring itselfwithin the lung passageway. Typically, the pre-curvature shape recoveryself-expands portions of the anchoring element 2004 outwardly so as torest against at least one wall of the lung passageway, such as in a ringsurrounding the inner surface of the lumen of the lung passageway. Thisallows the anchoring element 2004 to anchor within the lung passagewaywhile keeping the lung passageway patent. This can also assist inpreventing collapse of the lumen and ensures that the device 2000 doesnot obstruct the lumen in any way which may collect mucus. In someembodiments, the loop stent design of the anchoring element 2004 isapproximately the same size as the tissue gathering elements 2006 a,2006 b so it is also stronger than the inversion elements 2002 a, 2002b. This allows the inversion elements 2002 a, 2002 b to be deformedgreatly and yet the anchoring element 2004 can overcome the tension todilate in a transverse direction (toward the walls of the lungpassageway) relative to the direction that the tension is being appliedto the device 2000.

It may be appreciated that the device 2000 is still attached to theplunger 2222 even after the anchoring element 2004 has been deployedfrom the catheter 2106. After deploying the anchoring element 2004, thedevice 2000 can optionally be pulled back into the catheter 2106 toreposition the anchoring element 2004 or further tension the damagedtissue DT. The anchoring element 2004 can then be re-deployed. It may beappreciated that, in a similar manner, the entire device 2000 canoptionally be recovered and redeployed if desired. FIG. 149 illustratesthe anchoring element 2004 released from the plunger 2222, leaving theanchoring element 2004 firmly anchored within the lung passageway. Thisis achieved by retracting the sheath 2228, thereby exposing the cutoutof the coupling element 2226, by pressing the push button 2232. The pushbutton 2232 is configured so that full depression of the push button2332 advances the coupling element 2226 a predetermined distance so thatthe cutout clears the sheath 2228. This allows the attachment feature2020 to release from the cutout of the coupling element 2226. It may beappreciated that the cut-out of the coupling element 2226 is angled sothat the attachment feature 2020 easily slips out of the cutout, even ifthe coupling element 2226 is pinned against the wall of the lungpassageway. The plunger 2222 and all parts of the delivery system canthen be removed. In some embodiments, the anchoring element 2004 isconfigured so that the distance d5 is 2-30 mm, such as 10-15 mm or 12mm. Likewise, in some embodiments, the attachment feature 2020 has awidth shown as distance d6 of 0.5-5 mm, such as 2 mm.

FIG. 149 illustrates how the device 2000 may appear 1-48 hours afterdeployment. Here, the inversion elements 2002 a, 2002 b are stillextended which provides chronic tension to the device 2000. Thus, as thelung tissue relaxes, any slack will be taken up by the recoil force ofthe inversion elements 2002 a, 2002 b. In addition, the flexibility ofthe device 2000 allows the device 2000 to cycle in length duringbreathing to maintain tension.

FIG. 150 illustrates how the device 2000 may appear over time. Here, theinversion elements 2002 a, 2002 b have recovered toward its originalpre-formed shape. Evolving slack, caused by continued effects ofemphysema in the lung tissue, has been pulled toward the anchoringelement 2004 as it develops. It may be appreciated that the strainrecovery provides chronic force. This maintains tensioning in the lung,such as for 0.1 to 20 years.

FIG. 151 illustrates how the device 2000 may appear over a longer periodof time. Here, the inversion elements 2002 a, 2002 b have fullyretracted to its original pre-formed shape. Evolving slack in the lungtissue has been additionally pulled toward the anchoring element 2004over time. This maintains tensioning in the lung over long periods oftime.

It may be appreciated that various aspects of the above describedpulmonary treatment devices may be combined in any combination. Forexample, the invertible pulmonary treatment devices 2000 may beconfigured to allow rotation or torqueing of tissue during placement.Likewise, the torque-based pulmonary treatment devices 400 may beconfigured to invert during placement. Further, any of the pulmonarytreatment devices may be configured to act as a clip so as to drawairways together. Thus, elements of any pulmonary treatment devices maybe combined with any others. Descriptive aspects applying to an elementin one embodiment, such as a tissue gathering element, may be applied toanother embodiment having the same element or an element configured toperform the same or similar function.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1. (canceled)
 2. A pulmonary treatment device for treating a lungcomprising: at least one tissue gathering element having a shapeconfigured to grasp tissue in the lung; an anchoring element having ashape configured to be positioned within a lung passageway of the lung;and at least one inversion element configured to invert duringimplantation of the pulmonary treatment device and relax thereafter soas to draw the grasped tissue toward the anchoring element.
 3. Apulmonary treatment device as in claim 2, wherein the pulmonarytreatment device has a longitudinal axis and wherein the pulmonarytreatment device is configured to be loaded into a delivery device so asto extend along its longitudinal axis.
 4. A pulmonary treatment deviceas in claim 3, wherein the at least one tissue gathering elementcomprises at least one distal tip configured to rotate around a secondaxis upon deployment from the distal end of the delivery device into thetissue of the lung so as to grasp the tissue.
 5. A pulmonary treatmentdevice as in claim 4, wherein continued deployment of the at least onetissue gathering element from the delivery device allows the at leastone inversion element to curve around a third axis.
 6. A pulmonarytreatment device as in claim 5, wherein and continued deployment deploysthe anchoring element from the delivery device into the lung passagewayof the lung.
 7. A pulmonary treatment device as in claim 2, wherein thepulmonary treatment device has a longitudinal axis and wherein each ofthe at least one tissue gathering element wraps around an axissubstantially perpendicular to the longitudinal axis upon deployment. 8.A pulmonary treatment device as in claim 2, wherein the at least onetissue gathering element has a shape configured to wind into the tissueupon deployment so as to grasp the tissue.
 9. A pulmonary treatmentdevice as in claim 8, wherein each of the at least one tissue gatheringelements has a helical shape that corkscrews into the tissue upondeployment so as to grasp the tissue.
 10. A pulmonary treatment deviceas in claim 2, wherein the pulmonary treatment device is formed from acontinuous shaft.
 11. A pulmonary treatment device as in claim 10,wherein the at least one tissue gathering element comprises two tissuegathering elements, each of the two tissue gathering elements formedfrom opposite ends of the continuous shaft.
 12. A pulmonary treatmentdevice as in claim 11, wherein the at least one inversion elementcomprises two inversion elements, each of the two inversion elementsformed from a portion of the continuous shaft adjacent to one of the twotissue gathering elements.
 13. A pulmonary treatment device as in claim12, wherein the anchoring element is formed from a portion of thecontinuous shaft between the two inversion elements.
 14. A pulmonarytreatment device as in claim 2, wherein the at least one inversionelement has a lower modulus of elasticity than the at least one tissuegathering element.
 15. A pulmonary treatment device as in claim 2,wherein the at least one inversion element comprises at least twoconcentric loops.
 16. A pulmonary treatment device as in claim 2,wherein the at least one inversion element is disposed between the atleast one tissue gathering element and the anchoring element when thepulmonary treatment device is in a tensioned configuration and whereinthe at least one inversion element moves the at least one tissuegathering element between the at least one inversion element and theanchoring element as the pulmonary treatment device transitions toward arelaxed configuration.
 17. A pulmonary treatment device for treating alung comprising: a body having a distal end, a proximal end and alongitudinal axis, wherein the body is configured to be loaded within adelivery device, wherein the distal end comprises at least one distaltip configured to rotate around a second axis upon deployment from thedistal end of the delivery device into tissue of the lung, whereincontinued deployment of the distal end from the delivery device allowsthe distal end to form at least one energy storage element which curvesaround a third axis, and wherein continued deployment deploys theproximal end from the delivery device into a lung passageway of thelung.
 18. A pulmonary treatment device as in claim 17, wherein the atleast one energy storage element stores energy by inversion.
 19. Apulmonary treatment device as in claim 17, wherein distal end comprisestwo tissue gathering elements each having one of the at least one distaltip, each of the two tissue gathering elements having a helical shapewinding away from each other.
 20. A pulmonary treatment device as inclaim 17, wherein the pulmonary treatment device is formed from acontinuous shaft.
 21. A pulmonary treatment device for treating a lungcomprising: at least one tissue gathering element having a shapeconfigured to grasp lung tissue; an anchoring element having a shapeconfigured to anchor within a lung passageway of the lung, wherein thetissue gathering element is opposite the anchoring element along alongitudinal axis when the pulmonary treatment device is in a tensionedconfiguration; and at least one inversion element disposed between theat least one tissue gathering element and the anchoring element when thepulmonary treatment device is in the tensioned configuration, whereinthe at least one inversion element moves the at least one tissuegathering element between the at least one inversion element and theanchoring element as the pulmonary treatment device transitions toward arelaxed configuration.